House Hearing, 113TH Congress - Health Information Technologies: Administration Perspectives On Innovation and Regulation

HEALTH INFORMATION TECHNOLOGIES: ADMINISTRATION PERSPECTIVES ON INNOVATION AND
REGULATION
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND

INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND

COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
MARCH 21, 2013
Serial No. 11322
(
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CHRIS
COMMITTEE ON ENERGY AND COMMERCE

FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas
HENRY A. WAXMAN, California
JOE BARTON, Texas
Ranking Member
Chairman Emeritus
JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky
Chairman Emeritus
JOHN SHIMKUS, Illinois
EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania
FRANK PALLONE, JR., New Jersey
BOBBY L. RUSH, Illinois
GREG WALDEN, Oregon
ANNA G. ESHOO, California
LEE TERRY, Nebraska
ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan
GENE GREEN, Texas
TIM MURPHY, Pennsylvania
DIANA DEGETTE, Colorado
MICHAEL C. BURGESS, Texas
LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee
MICHAEL F. DOYLE, Pennsylvania
Vice Chairman
JANICE D. SCHAKOWSKY, Illinois
PHIL GINGREY, Georgia
ANTHONY D. WEINER, New York
STEVE SCALISE, Louisiana
JIM MATHESON, Utah
ROBERT E. LATTA, Ohio
CATHY MCMORRIS RODGERS, Washington G.K. BUTTERFIELD, North Carolina
GREGG HARPER, Mississippi
JOHN BARROW, Georgia
LEONARD LANCE, New Jersey
DORIS O. MATSUI, California
BILL CASSIDY, Louisiana
DONNA M. CHRISTENSEN, Virgin Islands
BRETT GUTHRIE, Kentucky
KATHY CASTOR, Florida
PETE OLSON, Texas
JOHN P. SARBANES, Maryland
DAVID B. MCKINLEY, West Virginia
JERRY MCNERNEY, California
BRUCE L. BRALEY, Iowa
CORY GARDNER, Colorado
PETER WELCH, Vermont
MIKE POMPEO, Kansas
BEN RAY LUJAN, New Mexico
ADAM KINZINGER, Illinois
PAUL TONKO, New York
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
(II)
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CHRIS
SUBCOMMITTEE
ON
OVERSIGHT
AND
INVESTIGATIONS
TIM MURPHY, Pennsylvania

Chairman
MICHAEL C. BURGESS, Texas
DIANA DEGETTE, Colorado
Ranking Member
Vice Chairman
BRUCE L. BRALEY, Iowa
MARSHA BLACKBURN, Tennessee
BEN RAY LUJAN, New Mexico
PHIL GINGREY, Georgia
EDWARD J. MARKEY, Massachusetts
STEVE SCALISE, Louisiana
JANICE D. SCHAKOWSKY, Illinois
GREGG HARPER, Mississippi
G.K. BUTTERFIELD, North Carolina
PETE OLSON, Texas
KATHY CASTOR, Florida
CORY GARDNER, Colorado
PETER WELCH, Vermont
H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York
BILL JOHNSON, Ohio
GENE GREEN, Texas
BILLY LONG, Missouri
JOHN D. DINGELL, Michigan
RENEE L. ELLMERS, North Carolina
HENRY A. WAXMAN, California (ex officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)
(III)
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CONTENTS
Page
Hon. Tim Murphy, a Representative in Congress from the Commonwealth

of Pennsylvania opening statement ....................................................................
Prepared statement ..........................................................................................
Hon. Diana DeGette, a Representative in Congress from the state of Colorado,
opening statement ................................................................................................
Hon. Michael C. Burgess, a Representative in Congress from the State of
Texas, opening statement ....................................................................................
Hon. Marsha Blackburn, a Representative in Congress from the State of
Tennessee ..............................................................................................................
Hon. Henry A. Waxman, a Representative in Congress from the State of
California, opening statement .............................................................................
1
3
4
6
6
7
WITNESSES
Christy Foreman, Director, Office of Device Evaluation, Center for Devices
and Radiological Health, Food and Drug Administration ................................
Answers to submitted questions ......................................................................
Farzad Mostashari, National Coordinator, Health Information Technology,
U.S. Department of Health and Human Services .............................................
Answers to submitted questions ......................................................................
9
12
61
21
23
66
SUBMITTED MATERIAL
Letter of March 20, 2013, from the FDA to the Committee, submitted by
Ms. DeGette ..........................................................................................................
57
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HEALTH
INFORMATION
TECHNOLOGIES:
ADMINISTRATION PERSPECTIVES ON INNOVATION AND REGULATION
THURSDAY, MARCH 21, 2013
SUBCOMMITTEE
HOUSE OF REPRESENTATIVES,
ON OVERSIGHT AND INVESTIGATIONS,
COMMITTEE ON ENERGY AND COMMERCE,
Washington, DC.
The subcommittee met, pursuant to call, at 9:08 a.m., in room
2322 of the Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Present: Representatives Murphy, Burgess, Blackburn, Harper,
Olson, Griffith, Johnson, Long, Ellmers, Barton, DeGette,
Butterfield, Tonko, and Waxman (ex officio).
Staff present: Mike Bloomquist, General Counsel; Matt Bravo,
Professional Staff Member; Karen Christian, Chief Counsel, Oversight; Andy Duberstein, Deputy Press Secretary; Julie Goon,
Health Policy Advisor; Debbee Hancock, Press Secretary; Brittany
Havens, Staff Assistant; Sean Hayes, Counsel, O&I; Robert Horne,
Professional Staff Member, Health; Peter Kielty, Deputy General
Counsel; Katie Novaria, Legislative Clerk; John OShea, Professional Staff Member, Health; David Redl, Counsel, Telecom; Alan
Slobodin, Deputy Chief Counsel, Oversight; Jean Woodrow, Director, Information Technology; Tiffany Benjamin, Democratic Senior
Counsel; Brian Cohen, Democratic Staff Director, Oversight & Investigations, Senior Policy Advisor; Eric Flamm, FDA Detailee;
Elizabeth Letter, Democratic Assistant Press Secretary; Stephen
Salsbury, Democratic Special Assistant; Rachel Sher, Democratic
Senior Counsel; and Matt Siegler, Democratic Counsel.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. MURPHY. All right. Good morning, everyone, and welcome to

our hearing today on Health Information Technologies: Administrative Perspectives on Innovation and Regulation. Thank you for
being here. Today, we convene the Subcommittee on Oversight and
Investigations to discuss development and innovation and these
technologies, particularly mobile medical applications or apps,
and how federal regulations may impact this growing industry.
We are joined by two witnesses from the Administration, Dr.
Farzad Mostashari, who is the head of the Office of the National
Coordinator with HHS; and Christy Foreman, who is the director
(1)
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2
of the Office of Device Evaluation in the Center for Devices and Radiological Health at the FDA. Both of these agencies have been
leading the governments response to the rapid changes that new
technologies are making to our Nations healthcare system.
On March 4, this committee sent a letter to the FDA on its approach to regulating the rapidly growing market applications used
on smartphones and tablets. With this explosive growth, the use of
those apps to monitor health information is growing, as well as increasing in accuracy and technological sophistication. News reports
indicate that there are as many as 40,000 medical applications on
the market for smartphones and tablets.
We are here today to discuss the discretion FDA has an regulating these apps as devices under the Food, Drug, and Cosmetic
Act, and over the last few days, we have heard a number of examples of medical apps and concerns from apps companies about
whether these apps are devices. For example, where does an app
that transmits photos of potential skin cancer or the healing of surgical scars cross the line to FDA scrutiny? If an app that turns a
smartphone into an ultrasound can be regulated, what about apps
that let you review images from ultrasound or x-rays?
You know, there has been incredible advances in all these things
and we expect to see more in not only areas of dermatology in the
use of photos, endocrinology with monitoring blood glucose levels,
x-rays with radiology and orthopedics, heart monitors with cardiology, mental status tests with neurology. The list goes on and on.
In 2011 the FDA issued Draft Guidance on how the Agency
planned to regulate mobile medical applications. The FDA has not
yet issued Final Guidance. To our witnesses from the FDA, over
the last 2 days we have heard from a variety of witnesses and
members of both sides of the aisle, and the message was clear: we
need Final Guidance. The developers of these apps and the
healthcare industry need certainty.
That certainty is also needed because of the tax on medical devices put in place by the new healthcare law. As we have heard
this week, a tax on medical devices can make capital needed to develop these apps and new breakthrough technologies more scarce.
This can slow innovation. And we are caught in its cycle of the
snake eating its own tail whereby we raise taxes on medical devices, thus increasing the costs, and then use those taxes to subsidize increased costs and offer tax incentives to cover R&D. It
doesnt quite make sense but we want to make sure we are not
slowing innovation.
So this isnt about scaring people into thinking this tax will apply
to their iPhones, Blackberries, or iPads, but this tax could absolutely halt the development of new apps to run on those devices.
Everyone here recognizes the need to balance patient safety and innovation. I hope that todays hearing will provide some certainty
that regard.
We will also hear from Dr. Mostashari on the efforts that have
been made by the Department of Health and Human Services to
encourage the utilization of health information technology, and particularly, the incentive payments that have been made to providers
to adapt to new healthcare technologies. Recently, HHS announced
that for this year they hope to have 50 percent of physicians offices
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using electronic health records with 80 percent of eligible hospitals
receiving incentive payments by the end of this year.
While the movement to increased use of electronic health records
may seem like an obvious choice as doctors and hospital employees
become more comfortable with new technologies, as a supporter of
health IT, I am concerned that the promised benefits of electronic
medical records have yet to arrive. I have personally heard from
physicians in my district who have struggled to adapt or received
unclear Guidance from the Agency. Of particular concern are complaints that systems in place arent able to share information with
other systems. I hope our witnesses today will be able to address
these concerns over interoperability.
I am encouraged by the work this committee has done this week.
We have had a great dialogue on these issues and today I hope we
will be able to hear the Administrations view on its approach to
innovation and regulation of healthcare technologies.
I also want to apologize ahead of time. I have another hearing
that I have to testify, and I will be leaving in a little bit, but it
will be taken over by the capable hands of the vice chairman, Dr.
Mike Burgess.
[The prepared statement of Mr. Murphy follows:]
PREPARED
STATEMENT OF
HON. TIM MURPHY
Today we convene the Subcommittee on Oversight and Investigations to discuss

development and innovation in health care technologies, particularly mobile medical
applications or apps, and how federal regulations may impact this growing industry.
Today we are joined by two witnesses from the administration: Dr. Farzad
Mostashari is the head of the Office of the National Coordinator within HHS.
Christy Foreman is the Director of the Office of Device Evaluation within the Center for Devices and Radiological Health at FDA.
Both of these agencies have been leading the governments response to the rapid
changes being made to the health care industry by new technologies.
On March 4, this Committee sent a letter to the FDA on its approach to regulating the rapidly growing market for applications used on smartphones and tablets.
With this explosive growth, the use of those apps to monitor health information is
growing as well. News reports indicate that there are as many as 40,000 medical
applications on the market for smartphones and tablets, and it is expected to grow.
We are here today to discuss the discretion FDA has to regulate these apps as
devices under the Food, Drug, and Cosmetic Act. I have seen that in todays testimony the FDA is now definitely saying: NO, we will not regulate the general sale
of smartphones or tablets-I thank the FDA for providing certainty on this matter.
Yet, over the last few days we have heard a number of examples of medical apps
and concerns from apps companies about whether these apps are devices. For example, where does an app that transmits photos of potential skin cancer cross the line
to FDA scrutiny? If an app that turns a smartphone into an ultrasound can be regulated, what about apps that let you view images from an ultrasound or xray?
In 2011, the FDA issued draft guidance on how the agency planned to regulate
mobile medical applications. FDA has not yet issued final guidance. To our witness
from the FDA, over the last two days we have heard from a variety of witnesses
and members of both sides of the aisle-the message is clear: we need final guidance.
The developers of these apps and the health care industry needs certainty.
That certainty is also needed because of the tax on medical devices put in place
by the new healthcare law. As we have heard this week, a tax on medical devices
can cause money for the development of these apps and the advancement of medical
technology to become more scarce. It can slow innovation. Ive heard a lot from my
Democrat colleagues about how were trying to scare people into thinking this tax
will apply to their iPhones, Blackberries or iPads, but they dont seem to be concerned that the problem is that it could halt the development of new apps to run
on those devices.
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Everyone here recognizes the need to balance patient safety and innovation. I
hope that todays hearing will provide some certainty on that balance.
We will also hear from Dr. Mostashari on the efforts that have been made by the
Department of Health and Human Services to encourage the utilization of health
information technology, and particularly the incentive payments that have been
made to providers to adapt to new health care technologies. Recently HHS announced that for this year they hope to have 50 percent of physician offices using
electronic health records, with 80 percent of eligible hospitals receiving incentive
payments by the end of the year. 1A1
While the movement to increased use of electronic health records may seem like
an obvious choice as doctors and hospital employees become more comfortable with
new technologies, this Committee is concerned whether their effectiveness has been
oversold. In the last few months we have seen reports indicating that the savings
promised by electronic health records may have yet to materialize while doctors
struggle to adapt. Of particular concern are complaints that some of the systems
being utilized may not be able to share information with other systemsand I hope
our witness today will be able to address these concerns over interoperability.
I am proud of the work this Committee has done this weekwe have had a great
dialogue on these issues and today I hope well be able to hear the administrations
views on its approach to innovation and regulation of health care technologies.
Mr. MURPHY. And now, I would like to recognize Ms. DeGette for
her opening statement.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO
Ms. DEGETTE. Thank you very much, Mr. Chairman.

Mobile medical apps and electronic health records are developing
at a rapid pace and they have the capacity to transform the patient-doctor relationship, improve healthcare quality, and also to
save billions of dollars. And I am looking forward to hearing from
the FDA and HHS about the efforts to integrate these new technologies into the healthcare sector.
Dr. Mostashari, I want to welcome you, the national coordinator
for Health Information Technology.
The 2009 stimulus bill contained billions of dollars to help
incentivize doctors and hospitals to implement meaningful use of
electronic medical records. That investment has already made a big
difference. Since 2009, the use of electronic health records by physicians has doubled from 20 to 40 percent in the hospital adoption
of electronic health records has more than tripled. More than
230,000 healthcare providers have qualified for payments for implementing the use of electronic health records. Ultimately, the
adoption of these records will reduce medical errors, save money,
and most importantly, improve the quality of care.
Earlier this week, the Premier Healthcare Alliance reported that
333 hospitals in their network had, since 2008, save $9.1 billion
and avoided 92,000 deaths by implementing a set of patient-centered quality improvement reforms that was made possible in part
by enhanced data-sharing and use of health information technology. But the transition to electronic health records is not without challenges, and Dr. Mostashari, I am glad you are here to address questions about the Agencys roadmap to help us fully implement health IT.
11
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Ms. Foreman, I also want to welcome you to talk about the
FDAs role in regulating and improving mobile medical apps.
Mr. Chairman, I have got to admit the discussion of FDAs role
in regulating medical apps seems a little redundant. This is the
third hearing that is focused on these issues. As we heard during
the first two hearings, the other subcommittee heard from 11 different nongovernment witnesses about how the Administration is
balancing the need to promote innovation in this field against the
need to ensure patient safety. Those witnesses thankfully already
debunked some of the biggest myths that we have heard from the
outside about the FDAs role. Thank goodness the myth of the
iPhone tax has now been put to rest.
We also learned from the witnesses that smartphones and tablets
are exempt from the Affordable Care Act medical device tax. We
learned that the FDA is not currently and does not intend in the
future to regulate smartphones or tablets as part of its regulation
of mobile medical apps. We also learned that the FDA does not intend to regulate calorie counters or pedometers or other kinds of
similar apps as medical devices. But we also learned about how the
Agency has a role in ensuring that other medical devices like monitoring blood glucose or providing other vital medical information
are accurate and work the way they are supposed to do, which is
exactly what the FDA is therefore.
But the Committee also heard from some industry witnesses expressing concerns about the FDAs regulatory efforts and worrying
that they could overreach and limit innovation. These concerns are
not new and they are not specific to mobile medical apps. FDA, and
frankly this committee, has to constantly address this balance,
whether the Agency is regulating food, drugs, traditional medical
devices, or these apps. That is part of what we have to do.
The FDA addressed all of these concerns in a letter that was sent
to the Committee yesterday and, Mr. Chairman, I would like to ask
that the letter be made part of the hearing record. The letter
makes it abundantly clear that the FDA will not tax your iPhone
and it provides new information that shows for the mobile medical
apps FDA has reviewed, those reviews are moving quickly, taking
an average of only 67 days. So to me that sounds pretty much like
an agency that is trying to foster innovation while at the same time
ensuring that patients are safe.
And so, Mr. Chairman, I dont think that the debate over how
to balance patient safety and innovation will end any time soon,
but I am hopeful that at least we can have a common understanding of the facts with regard to electronic health records and
mobile medical apps, and we can continue in our joint effort with
the agencies to make sure we balance innovation and safety.
And with that, Mr. Chairman, I yield back and thank you.
Mr. MURPHY. Thank you. And we do have a copy of this letter
for the record, but I thank the ranking member for bringing that
up again.
I now yield to Dr. Burgess for 5 minutes for an opening statement.
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OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS
Mr. BURGESS. I thank the chairman. And certainly we have

heard from a number of qualified and distinguished scientists and
specialists in medical technology and the communications industries for the past two hearings, and today, we are going to hear the
perspectives of the agencies that wrote the proposed regulations
guiding these industries.
The emergence of mobile medical technology does hold great
promise not only for lowering the care cost, but most importantly,
for improving health outcomes. The increasing availability of these
technologies has revolutionized how providers interact with patients. We are at a point now where the number of providers using
these devices has increased, almost doubled, from a year ago such
that nearly 2/3 of providers are using some type of device. The
rapid proliferation of these new technologies also raises legitimate
concerns about patient safety, but we also want to encourage important advancements that can improve patients quality of life.
And it is not just the overregulation by the government but it is
the uncertainty of pending regulation that also drives some of this
discussion.
The FDA struggles to maintain their current regulatory charge,
but we need to be assured that they have the experience, that they
have the expertise to handle the additional responsibilities of an
emerging market.
Ms. Foreman, I would like to thank you and your agency for the
rapid response to the letter earlier this week. I hope that sets a
new benchmark in the Administration. We are accustomed to waiting years for a response, and this was indeed refreshing that it was
only a few weeks in turnaround. And certainly, we look forward to
similar quick turnaround for the final regulations of the Draft
Guidance, which was issued in July 2011.
And Dr. Mostashari, I have enjoyed visiting with you in the past,
and I thank you for being with us as well.
As a provider, I have direct experience using health information
technology and seeing the benefits as well as some of the downfalls
that it brings to both patients and providers. Artificial barriers do
nothing for care coordination, for patient safety, or for provider
communication. As a physician, my primary concern is the health
and safety of the patient. Inaction is not an option on this issue.
However, we must do so in a way that encourages the development
of innovative technologies, and we certainly do not want to push
them outside of our borders.
I will now yield the balance of the opening statement time to the
gentlelady from Tennessee, Mrs. Blackburn.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE
Mrs. BLACKBURN. And I thank the gentleman for yielding. And

thank you, Mr. Chairman, for the hearing. And to our witnesses,
Ms. Foreman, Dr. Mostashari, we thank you for being here with us.
The hearings that we have done this week I think are essential.
I dont think they are redundant. I do think they are essential to
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getting our arms around an issue that we are going to have to deal
with on mobile medical apps. And I would say that one of the
things that has come forward through the testimony we have received is that a 40-year-old FDA statute is not nimble enough to
address the needs that are in front of us with this new innovation
sector.
I do think that ONC has a unique perspective on these HIT
issues, and along with input from the FDA and from stakeholders
that Congress can find a path forward on what a framework would
look like. One of the things we have heard from the innovators is
the uncertainty that is there within FDA. This big gray area of
whether you will or will not be regulated, that is stifling innovation. And as we heard in the hearing on Tuesday, it also does not
do anything to provide certainty to investors who are going to be
there. So that is of concern to us.
Now, Dr. Burgess mentioned yesterday that these are the tools
of todays doctors and future doctors, and 15 percent of these apps
that are out there, the 97,000 apps, the mobile medical apps, 15
percent are used by physicians. This is a way for us to achieve efficiency. It is a way for us to expand access, and what we want to
be certain is that our innovators know with certainty what their
classification would be, how they would be dealt with as an industry.
So we thank you all for the testimony and for being here and we
look forward to concluding our series and finding a way forward on
the issue.
And I yield back.
Mr. MURPHY. Thank you.
I now recognize the ranking member of the full committee for an
opening statement, 5 minutes, Mr. Waxman.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA
Mr. WAXMAN. Mr. Chairman, we are here today for the third day
in a row to discuss electronic health records and FDAs regulation
of mobile medical apps, and I am surprised at the amount of time
and attention given to this issue.
I have attended the last 2 days of hearings, and from what I
have heard, the members on your side of the aisle seek to answer
two basic questions: question one, whether the FDA is regulating
mobile medical apps with too heavy a hand; is the Agency impeding innovation and harming this market by regulating too aggressively or approving mobile medical apps too slowly?
This is not a new responsibility for FDA. For over 100 years the
Agency has been balancing patient and consumer safety with the
need for innovation. In the case of mobile medical apps, the answers that we heard in the first 2 days of hearings indicate little
by way of concern. The witnesses told us that they understood the
role of FDA and the need for agency regulation and were unable
to point out any legitimate examples of apps that FDA was improperly regulating under its Draft Guidance. Although they had some
anxiety about it, they had nothing to point to.
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Question two is whether FDA will impose a new tax, the Affordable Care Act medical device tax, on your cell phone. The answer
to this question is as plain as day. The answer is no. The Affordable Care Act itself contains a clear retail exemption. Even if a cell
phone was designated to be a medical device, the Act says that any
device that is generally purchased by the general public at retail
for individual use is not subject to the tax. That exemption would
apply to any cell phone you can buy at a retail store. And FDA has
been clear that the Agency is not currently regulating and does not
intend in the future to regulate smartphones or tablets as part of
its regulation of mobile medical apps. The IRS has provided similar
indications.
Mr. Chairman, this issue is a non-issue. We did not need to
spend 1 day of hearings on this, let alone 3. This committee could
have used this time more wisely. I have asked you to hold hearings
on the abuse of tax and regulatory loopholes by the tobacco industry and their efforts to undermine the Tobacco Control Act. Ranking Member DeGette and I have asked for hearings on the impacts
of sequestration on the agencies of our committees jurisdiction. We
have asked for hearings on the risks associated with antibiotic-resistant bacteria, a very serious and growing public health threat.
We have asked for you to hold hearings on Lifeline, the Universal
Service Funds low income phone program. These hearings could
examine the expenditure of billions of dollars of consumer funds.
In the last 2 years, I have sent over 20 letters asking for hearings on the impacts of climate change. And we have not held a
hearing on a single one of these important issues. Mr. Chairman,
I hope you can understand our concern. I dont mean to discount
the importance of mobile medical apps and the electronic health
records. This is an industry that, thanks to the investment we
made in the 2009 Obama stimulus bill, is growing, is creating jobs,
and has the potential to dramatically improve healthcare quality
and save billions of dollars in healthcare costs.
But there are too many pressing issues before us for this committee and this Congress to get bogged down for 3 days in what
amounts to an inaccurate talking point about FDA overregulation
and the nonexistent iPhone tax. I hope that in the future this subcommittee can use its time more wisely. I must say, Mr. Chairman,
for this particular subcommittee, I thought that the first hearings
we have held under your leadership have been very worthwhile
and that we can go back to doing things that are constructive and
not just talking points for political purposes, which is all these 3
days have been about.
I yield back the balance of my time.
Mr. MURPHY. Thank you very much, Mr. Waxman. I would now
like to recognize Christy Foreman. She is currently the director of
the Office of Device Evaluation for the Center for Devices and Radiological Health for the FDA. Before being named to the director
position, she served as the deputy director for Science and Regulatory Policy in the Office of Device Evaluation.
I would also like to introduce Farzad Mostashari. He currently
serves as national coordinator for Health Information Technology
within the Office of the National Coordinator for Health Informa-
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tion Technology at the U.S. Department of Health and Human
Services. Farzad joined ONC in July of 2009.
You are aware that the Committee is holding an investigative
hearing, and when doing so, has had the practice of taking testimony under oath. Do you have any objections to testifying under
oath?
Both witnesses have said they do not.
The chair then advises you that under the rules of the House and
the rules of the Committee, you are entitled to be advised by counsel. Do you desire to be advised by counsel during your testimony
today?
Both witnesses have said no.
In that case, if you please rise and raise your right hand, I will
swear you in.
[Witnesses sworn.]
Mr. MURPHY. And if someone could work on the volume, I would
appreciate that, too.
You are now under oath and subject to the penalties set forth in
Title XVIII, Section 1001 of the United States Code. You may now
give a 5-minute summary of your written statements. Ms. Foreman, if you would like to begin.
TESTIMONY OF CHRISTY FOREMAN, DIRECTOR, OFFICE OF
DEVICE EVALUATION, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION; AND
FARZAD MOSTASHARI, NATIONAL COORDINATOR, HEALTH
INFORMATION TECHNOLOGY, U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES
TESTIMONY OF CHRISTY FOREMAN
Ms. FOREMAN. Mr. Chairman, Ranking Member DeGette, and

members of the subcommittee, I am Christy Foreman, Director of
the Office of Device Evaluation in the Center for Devices and Radiological Health, or CDRH, at the Food and Drug Administration.
Thank you for the opportunity to testify today. I am pleased to be
here to discuss issues related to health IT and to talk specifically
about the actions FDA is taking to foster innovation in the field of
mobile medical applications, also referred to as mobile medical
apps.
The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and healthcare delivery. Mobile apps, which are software programs that run on
smartphones and other mobile devices, can help consumers and patients manage their own health and wellness, promote healthy living, and gain access to useful information when and where they
need it.
FDA believes it is important to adopt a balanced approach to mobile medical apps that supports continued innovation while assuring appropriate patient protections. We also recognize that mobile
health application developers need a clear, predictable, and reasonable understanding of the Agencys expectations.
While many mobile apps carry minimal risk, others can pose significant risk to patients if they dont operate correctly. In some
cases, those risks are identical to the risks associated with an al-
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10
ready marketed medical device. For example, a mobile app that affects the programming of a drug infusion pump or a Computed Tomography scanner could lead to a drug or radiation overdose. And
an inaccurate or malfunctioning mobile medical app designed to diagnose skin cancer could delay life-saving diagnosis and treatment.
In July 2011, FDA issued a Draft Guidance announcing our intention to exercise enforcement discretion for most mobile apps.
The Guidance also clarifies that the focus of our oversight will be
a small subset of mobile apps, which we refer to as mobile medical
apps. These are apps that meet the definition of a device in the
Federal Food, Drug, and Cosmetic Act and that are either intended
to be used as an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.
What our policy proposes is equally important as what our policy
does not propose. It would not regulate the sale or general consumer use of smartphones or tablets. It would not consider entities
that exclusively distribute mobile medical apps, such as the iTunes
App Store or the Android Market, to be medical device manufacturers. It would not consider mobile platform manufacturers to be
medical device manufacturers just because their mobile platform
could be used to run a mobile medical app regulated by FDA. It
would not require mobile medical app developers to seek agency reevaluation for minor iterative product changes. And it would not
apply to mobile apps that perform the functionality of an electronic
health record, an EHR system, or personal health record system.
We have received more than 130 written comments on our Draft
Guidance. The comment have been overwhelmingly supportive of
our narrow, tailored, risk-based approach, and we continue to receive many inquiries from industry stakeholders who are eager to
see this Guidance finalized. Some commenters have sought additional clarity on the types of mobile apps that would fall within the
scope of enforcement discretion. Our Final Guidance will provide
that additional clarity and examples.
Pursuant to Section 618 of the Food and Drug Administration
Safety and Improvement Act (FDASIA), the FDA, the Office of the
National Coordinator, and the Federal Communications Commission have established a FDASIA workgroup which will provide expert input from a wide range of stakeholders to develop recommendations on an appropriate, risk-based regulatory framework
pertaining to health information technology, including mobile medical apps.
It is important to note that FDA has been regulating medical device software for decades, and medical device software on mobile
platforms for more than 10 years. We have reviewed approximately
100 mobile medical apps, including remote blood pressure, heart
rhythm, and patient monitor apps in addition to smartphone-based
ultrasound and glucose meters.
We recognize the importance of using a balanced, transparent
approach that fosters the development of innovative mobile medical
apps while ensuring appropriate patient protections. We intend to
strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps
that present a serious potential risk to patients if they do not work
as intended. We believe that focusing the Agencys oversight will
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11
encourage the development of new products while also providing
appropriate patient protections.
Thank you for the opportunity to testify today about issues related to health IT, including mobile medical apps, and about the
actions FDA is taking to foster innovation.
Mr. Chairman, I commend the Subcommittees efforts and am
pleased to answer any questions the Subcommittee may have.
[The prepared statement of Ms. Foreman follows:]
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12
HEALTH Al\D Hl'MAN SERVICES
Public Health Service
20993
STATEMENT
OF
CHRISTY L. FOREMAN
DIRECTOR, OFFICE OF DEVICE EVALUATION
CENTER FOR DEVIC.ES AND RADIOLOGICAL HEALTH
FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
COMMITTEE ON ENERGY AND COMMERCE
U.S. HOUSE OF REPRESENTATIVES
"HEALTH INFORMATION TECHNOLOGIES:

ADMINISTRATION PERSPECTIVES ON INNOVATION AND REGULATION"
l\farch 21, 2013
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Release Only On Delivery
13
INTRODUCTION
Chairman Murphy, Ranking Member DeGette, and Members of the Subcommittee, I am Christy
Foreman, Director of the Office of Device Evaluation in the Center for Devices and Radiological
Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I am pleased to be
here today to discuss issues related to health information technology (health IT), and to talk
specifically about the actions FDA is taking to foster innovation in the field of mobile medical
applications (mobile medical apps).
Health IT serves as the fundamental infrastructure that enables the management of health
information across multiple electronic systems and devices, such as wireless medical devices,
hospital information systems, communications infrastructures, and electronic health record
(EHR) systems.
The widespread adoption and use of mobile technologies is opening new and innovative ways to
improve health and health care delivery. Mobile applications (mobile apps)-software programs
that run on smartphones and other mobile communications devices--can help consumers
manage their own health and wellness, promote healthy living, and gain access to useful
information when and where they need it. Not surprisingly, these tools are being adopted almost
as quickly as they can be developed. In fact, industry estimates that 500 million smartphone
users worldwide will be using a health care application by 2015, I and by 2018, 50 percent of the
hcalthcarc mobile al'l""""'''''' in 20lS" (Nov. 10,2(10),
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]Ot5.
14
more than 3.4 billion smartphone and tablet users will have downloaded mobile health
applications. 2 Thcse users include health care professionals, consumers and patients.
FDA believes it is important to adopt a balanced, approach to mobile medical apps that supports
continued innovation, assuring appropriate patient protections. We also recognize that mobile
health application developers and manufacturers need a clear, predictable, and reasonable
understanding ofthe Agency's expectations.
Mobile apps span a wide range of health functions. While many mobile apps cany minimal or
no risk, others can pose significant risks to patients if they don't operate conectly. And, as we
will discuss, FDA's proposed guidance takes this variation in risk into account.
Consumers use mobile apps to manage their own health and wellness, such as to monitor their
caloric intake for healthy weight maintenance, or like the National Institutes of Health's
LactMed app, to provide nursing mothers with infom1ation about the effects of medicines on
breast milk and nursing infants. Other apps are aimed at helping health care professionals to
improve and facilitate patient care. such as the Radiation Emergency Medical Management
(REMM) app. which gives health care providers guidance on diagnosing and treating radiation
injuries. Some mobile apps can even diagnose cancer or heart rhythm abnormalities, or function
as the "central command" for a glucose meter used by an insulin-dependent diabetic patient.
Consumers and health care professionals should be aware of the potential benefits and risks
associated with technologies that incorporate mobile apps. In some cases those risks are similar
or identical to the risks associated with an already-marketed medical device. As an example.
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15
mobile apps that aHcct the programming of a drug infusion pump or computed tomography (CT)
scanner could lead to a drug or radiation overdose. An inaccurate or malii.mctioning mobile
medical app that uses a sensor to diagnose skin cancer or to measure critically low blood oxygen
levels in chronic lung disease patients, could delay lifesaving diagnosis and treatment.
FDA's 2011 Draft Guidance and Public Meeting
FDA has jurisdiction over those mobile apps that meet the definition of "device" in section
201(h) of the Federal, Food, Drug. and Cosmetic Act (FD&C Act) and the Agency intends to use
this authority reasonably and judiciously. FDA issued draft guidance in July 2011 3 to announce
its intention to exercise enforcement discretion for most mobile apps. The guidance also clarifies
that the focus ofFDNs oversight will be the small subset of mobile apps, referred to as mobile
medical apps, that meet the definition of "device" in section 201 (h) of the FD&C Act and that
are either intended to: (I) be used as an accessory to a regulated medical device,4 ill (2)
transform a mobile platform into a regulated medical device. 5 This narrowly tailored approach
would not require active FDA oversight of many apps that would otherwise meet the definition
of "device." Our draft guidancc clarified that a currently regulated medical device would not
become unregulated just because it was designed to work on a mobile platform. For example,
medical ultrasounds and electrocardiogram (EKG) machines are medical devices subject to FDA
review whether or not they are on a mobile platform. We believe that focusing FDA oversight
(March 4. 2013), available at

http,"~ 11'wH',l'esearch2guidal1ce,com "hop inde.r.()hp downloadable download sample sample td 262 .
3 FDA, "Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications" (July
21, 20 I I). available at
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an
a
cure professional to make a
medical image Jeom a picture archiving and communication system (PACS) on a smarttlho.ne
5 For example, an application that turns a smartphonc into an electrocardiograph
hear( rhythms or to detcrmine if a patient is experiencing a heart attack.
16
on a narrow subset of mobile apps will encourage the development of new products while
providing appropriate patient protections.
Just as important as what the policy proposes is what the policy does not propose. FDA's
proposed mobile medical apps policy would not regulate the sale or general consumer use of
smartphones or tablets. FDA's proposed mobile medical apps policy \vould not consider entities
that exclusively distribute mobile medical apI's, such as the owners and operators of the "iTunes
ApI' store" or the "Android market," to be medical device manufacturers. FDA's proposed
mobile medical apps policy would not consider mobile platlorm manufacturers to be medical
device manufacturers just because their mobile platform could be used to run a mobile medical
app regulated by FDA. FDA's proposed mobile medical apps policy would not require mobile
medical app developers to seek Agency re-evaluation for minor. iterative product changes.
FDA's proposed mobile medical app policy would not apply to mobile apI's that perform the
functionality of an electronic health record (EHR) system or personal health record system.
The draft guidance also states the Agency's intent to exercise enforcement discretion for those
mobile apps that do not meet the proposed definition of a mobile medical app, even if the mobile
app meets the FD&C Act's definition ofa "device."
Throughout the development of the mobile medical apps draft guidance and following its
issuance in July 2011. FDA has actively encouraged public feedback on how the regulatory
approach proposed in the draft guidance would affect the balance between promoting innovation
and providing reasonable assurance of safety and effectiveness. In addition to opening the draft
guidance for public comment, the Agency has interacted with the stakeholder community.
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including traditional medical device finns, software companies, health care professionals, patient
17
advocacy groups. health care facilities. third-party payers, and the health IT community. FDA
also hosted a widely attended public meeting to provide a forum tor discussion and to encourage
additional public comment from interested stakeholders on the issues raised in the draft
guidance. 6
In total, FDA has received more than 130 submissions to the public docket on the July 20 II draft
guidance. Respondents have overwhelmingly supported the narrowly tailored, risk-based
approach described in the draft guidance, and we continue to receive many inquiries from
industry stakeholders who are eager to see the guidance finalized. Some commenters have
sought additional clarity on the types of mobile apps that would fall within the scope of
enforcement discretion; the final guidance will provide such additional clarity and examples.
It is important to note that FDA has been regulating medical device software for decades and
medical device software on mobile platfonns for more than 10 years. The Agency has reviewed
approximately 100 mobile medical apps. including remote blood pressure, heart rhythm, and
patient monitors, and smartphone-based ultrasounds, EKG machines, and glucose monitors.
Some have questioned the implications of the medical device excise tax (device tax) enacted as
part ofthe Health Care and Education Reconciliation Act of2010 in cOI\junction with the Patient
Protection and Affordable Care Act for mobile medical apps. The Internal Revenue Service
(IRS) and the Department of the Treasury, not FDA. are responsible for the excise tax imposed
on the sale of certain medical devices. The IRS' final regulations 7 pertaining to the device tax
define a taxable medical device as "a device that is listed as a device with the FDA under 5100)
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12-13.2011." available at
18
of the FFDCA and 21 CFR Part 80T' and provide a "retail exemption" for medical devices that
are "generally purchased by the general public at retail for individual use." Questions about the
implementation of this policy should be directed at the IRS.
FDA developed the Agency's draft mobile medical apps policy to protect public health and
promote innovation. Because the draft guidance states that the Agency intends to exercise
enforcement discretion for certain categories of mobile apps with respect to applicable device
requirements. including listing. FDA does not expect such devices to list. FDA plans to provide
additional clarity regarding the specific types of apps for which the Agency intends to exercise
enforcement discretion in the final mobile medical apps guidance. The Agency intends to
maintain a publicly available website with updated information listing those apps which have
been cleared or approved by FDA and those for which FDA intends to exercise enforcement
discretion, in order to provide continuing clarity on this issue for industry and other stakeholders.
Developing an Appropriate, Risk-based Regulatory Framework for Health IT
Mobile medical apps represent just one component in an increasingly connected health care
environment. Three federal agencies-FDA, the Office of the National Coordinator for Health
Information Technology (ON C), and the Federal Communications Commission (FCC)-each
have unique and complementary responsibilities in the health IT arena. Section 618 of the Food
and Drug Administration Safety and Innovation Aet (FDASIA), enacted on July 9, 2012,
requires the Secretary of Health and Human Services, acting through the Commissioner of Food
and Drugs and in consultation with the National Coordinator for Health IT and the Chairman of
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FCC, to prepare a report by January 2014 containing "a proposed strategy and recommendations
19
on an appropriate, risk-based regulatory framework pertaining to health information technology,
including mobile medical applications, that promotes innovation, protects patient safety, and
avoids regulatory duplication.',g
FDA, ONC, and FCC have estahlished a "FDASIA Workgroup" under ONe's Health IT Policy
Committee (HITPC)9, which will provide expert input to ONe's HITPC to inform the
development of this report. Like ONC's other workgroups, it will be comprised ofa wide range
of stakeholders and conducted in a transparent manner with ample opportunity for public
comment.
CONCLUSION
FDA recognizes the importance of implementing a balanced, transparent approach that fosters
the development of health IT solutions and innovative products like mobile medical apps, while
ensuring appropriate patient protections, Like traditional medical devices, mobile medical apps
may in some cases present significant health risks to patients, FDA seeks to strike the right
balance by providing a risk-based, focused approach to the oversight o1'a small subset of mobile
medical apI's that present a potential risk to patients ifthey do not work as intended. Consistent
with this balanced approach, FDA would not regulate the sale or general consumer use of
smartphones or tablets.
Food and Drug Administration Safety and Innovation Act Public Law 112-144(126 Stat. 993) (July 9, 2012),
available at hllp: '11.",11'. gpo. go" fd'l's pkg PL.! 11'-1 npuN N~ pdfFL..! W-112puhlI 4.f.pdt:
q See FCC, "Membership Applications Sought for FDA Satety Innovation Act Workgroup," available at
http.-,','www(cc.gor membershiD-applicatio!1s-sought-fda-safetl'-innol'atiQI1-act-l-l'orkgroup. The Workgroup is being
formed under the ONC's HlTPC , a federal advisory committee established by the Health Information Technology
for Economic and Clinical Health (HITECll) Act (Title Xllf of the American Recovery and Reinvestment Act.
Public Law 111-5 (123 Stat. 115)(Feb. 17,2009). available at I!i.UL_11J11l',iJPO.!J,ITJsLIT5J2.kgPLAWI I Ipubl5 pdfPLAW-I I Ipuh/5.pd[.
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20
In its regulation of medical devices, the Agency strives for transparency, interaction,
collaboration, and the appropriate balancing of benefits and risks; ensuring predictable and
consistent recommendations, decision-making, and application ofthe least-burdensome
principle; and implementing efficient processes and use of resources. FDA's ongoing actions
with respect to the regulation of mobile medical apps. and the tri-Agency collaborative effort on
health IT, reflect this regulatory approach.
Thank you for your commitment to the mission of FDA and the continued success of our medical
device program, which helps to ensure that patients and health care professionals have access to
safe and effective innovative medical technologies. Thank you for the opportunity to testify
today about issues related to health IT, including mobile medical apps. and about the actions that
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FDA is taking to foster innovation. I am happy to answer questions you may have.
21
Mr. BURGESS [presiding]. The chair thanks the witness. I recognize Dr. Mostashari, 5 minutes for your opening statement, sir.
TESTIMONY OF FARZAD MOSTASHARI
Dr. MOSTASHARI. Dr. Burgess, Ranking Member DeGette, distinguished subcommittee members, thank you for the opportunity to
appear today on behalf of the Department of Health and Human
Services. My name is Dr. Farzad Mostashari. I am the National
Coordinator for Health Information Technology.
In 2009, HITECH was enacted as part of the American Recovery
and Reinvestment Act. HITECH provided the resources and infrastructure needed to stimulate the rapid, nationwide adoption and
use of health IT, especially electronic health records, or EHRs.
HITECH is working. The CMS Medicare and Medicaid EHR Incentive Program, the ONC-led Certification Program for EHRs, as well
as the hands-on technical assistance provided by 62 regional extension centers, or RECs, across the country are critical in facilitating
unprecedented progress in EHR development, adoption, and use.
There are now over 1,700 unique products produced by nearly
1,000 EHR developers and certified by 1 of 5 ONC-accredited private sector certification bodies. Adoption of EHRs has doubled
among providers and more than tripled in hospitals. Electronic prescribing has increased sevenfold. RECs have signed up more than
130,000 primary care providers in over 30,000 practices. As of February 2013, more than 230,000 providers, nearly 43 percent of the
Nations eligible professionals, and over 75 percent of eligible hospitals have earned payments for meeting the initial requirements
of EHR Incentive Program.
Recognizing the need to strike a balance between the urgency of
modernizing our healthcare system and the pace of change that can
be safely absorbed, CMS and ONC have developed the Incentive
Program in stages. Each stage is designed to add increasingly advanced concepts. Published in July 2010, the Stage 1 final rules focused on functionality that support the electronic capture of data
and its use to improve patient care, enhance care coordination in
population health management, and increase patient and family
engagement. The final rules for Stage 2 were published in September 2012 and represent an important next step with a focus on
increasing standards-based health information exchange between
providers and with patients.
Even as we work to bring data and data tools to doctors and hospitals, we have also been encouraged by the pace of progress in the
domain of consumer e-health tools. Increasingly, people are literally taking their health into their own hands. Mobile phones can
be an incredible tool for empowering consumers to take control of
their health, their care, their healthcare finances. And as we all
know, more engaged consumers get better outcomes.
ONCs strategy in consumer e-health is to work with partners to
increase patients ability to access their own health data, to increase the use of this data for actionable apps and services, and to
shift attitudes around patient empowerment. However, we recognize there are risks as well as benefits to any technology. We must
carefully balance the need for the widest possible innovation with
protection of patient privacy, security, and safety.
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Over the past 4 years, we have worked with FDA and other departmental agencies on a risk-based approach to health IT that
promotes innovation and avoids regulatory duplication. ONC advised FDA on the Draft Guidance for mobile medical apps. Where
it concerns EHR technologies, FDA has advised us on a health IT
patient safety action and surveillance plan, the draft of which was
released on December 21, 2012. The draft plan prescribes actions
that all stakeholders can take within their existing authorities and
resources, including safety requirements related to user-centered
design quality management systems and easier reporting of adverse events in ONC regulations, use of ONC-authorized testing
and certification bodies to collect complaints and conduct surveillance, working with developers to establish a code of conduct, working with AHRQ and patient safety organizations to improve aggregation and analysis of reported events and working with CMS to
train surveyors and use health IT to assist investigations. ONC has
received public comments on the draft plan, and those comments
have been generally favorable.
On February 20, ONC, FDA, and FCC announced the formation
of the Food and Drug Administrations Safety Innovation Act Work
Group under ONCs Health IT Policy Committee to provide expertise for the development of a congressionally mandated report on
an appropriate risk-based regulatory framework pertaining to
health IT broadly, including mobile medical applications that will
further promote innovation, protect patient safety, and avoid regulatory duplication. We are now in the process of reviewing nominations.
New technologies, including health IT and mobile applications,
offer great promise to improve the quality of care and bring down
healthcare costs. This doesnt happen overnight. To truly transform
delivery, healthcare providers must also redesigned workflows and
reengineer care. Payments must promote value over volume and
care that is better coordinated and safe. Implementation of any
program of this scale and complexity will inevitably include challenges, but by working within an open and transparent process and
in partnership with our public and private sector stakeholders, we
can build on this strong start in bringing better care to all Americans.
Thank you.
[The prepared statement of Dr. Mostashari follows:]
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23
Testimony before the Subcommittee on Oversight

and Investigations
Committee on Energy and Commerce
U.S. House of Representatives
Statement of
Farzad Mostashari, M.D., ScM.

National Coordinator, Office of the National Coordinator for
Health Information Technology
U.S. Department of Health and Human Services
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Health Information Technologies:

Administration Perspectives on Innovation and Regulation
March 21, 2013
24
Chairman Murphy, Ranking Member DeGette, and distinguished Subcommittee

members, thank you for the opportunity to appear today on behalf of the Department of
Health and Human Services (HHS).
My name is Dr. Farzad Mostashari and I am the National
Coordinator for Health Information Technology.

In 2009, Congress and President Obama enacted the Health Information Technology for
Economic and Clinical Health Act (HITECH) as part of the American Reinvestment and Recovery
Act of 2009 (ARRA).
HITECH established the Office of the National Coordinator for Health
Information Technology (ONe) by law and provided the resources and infrastructure needed to
stimulate the rapid, nationwide adoption and use of health IT, especially electronic health
records (EHRs).
Among other measures, HITECH included the establishment of the Medicare
and Medicaid EHR Incentive programs which provide technical assistance and financial
incentives to eligible professionals and hospitals that adopt and "meaningfully use" EHRs.
Thank you for the invitation to be here today to discuss how health IT benefits
patients and provides the tools that are necessary to transform care.
Already, HHS and its
partners have made significant progress expanding health information technology use.
Since 2009 physician EHR adoption has nearly doubled, growing to 40 percent in 2012, and
hospital EHR adoption has more than tripled over the same period, increasing to 44 percent.
In addition, I would like to provide a status report on HHS's Patient Safety Action &
Surveillance Plan and an update on the progress we have made in the relatively short time
since HITECH's passage.
Finally, I will conclude with an overview for what we have planned
in 2013 and beyond.
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25
Health IT is Transforming Care

Technology is just a tool but it is a critical tool that can foster much-needed
innovation in entrenched industries.
Our healthcare system is poised for a transformation
in how care is paid for and delivered and how patients engage in their own health and health
care. Health information technology supports these transformations.
In the past, our healthcare delivery system based its payments solely on the number of
services provided and not on the quality of care.
As a result, patients might receive
duplicative tests and/or services that might not improve their health.
As required by the
Affordable Care Act, HHS has launched several initiatives to more closely link payments with
quality outcomes and promote value-based care.
For example, the hospital readmissions
reduction program links hospital payments in Medicare to avoidance of potentially preventable

readmissions.
These reforms enable HHS to promote value over volume, and patient safety,
and ensure that care is better coordinated across the healthcare delivery system.
As both public and private payers take concrete steps to change the incentives for
paying providers, health IT can provide the infrastructure for improved care coordination,
better quality, and lower costs, as well as the data analytics that providers need to understand
the cost of doing business under the new payment models.
See Statement of Jonathan Blum on Delivery System Reform:
Progress Report from eMS:
Senate Committee
on Finance, February 28, 2013.
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26
Federal Advisory Committees: The HIT Policy and Standards Committees

Recognizing that health IT is a complex and quickly changing field, HITECH established
two Federal advisory committees under the Federal Advisory Committee Act (FACA).
The
Health IT Policy Committee was created to make recommendations on a policy framework to

support the development and adoption of a nationwide health information infrastructure.
The Health IT Standards Committee is responsible for making recommendations on standards,
implementation specifications, and certification criteria for the use and exchange of health
information.
Both the HIT Standards Committee and HIT Policy Committee include experts from the
private sector to help guide ONC and the Centers for Medicare & Medicaid Services (CMS) in
developing the rules for meaningful use and the certification of EHR technology.
HITECH
specified the different stakeholder perspectives that must be represented on the Committees.
The law explicitly charged the Comptroller General of the United States with the responsibility
of appointing 13 members representing various stakeholder groups to the Health IT Policy
Committee.
Additional perspectives are provided by the members appointed by the Secretary
of Health and Human Services, the Majority and Minority Leaders of the Senate, and the
Speaker and Minority Leader of the House of Representatives.
HITECH further specified that
the Health IT Standards Committee include providers, ancillary healthcare workers, consumers,
purchasers, health plans, technology vendors, researchers, relevant Federal agencies, and
individuals with technical expertise on health care quality, privacy and security, and health
information exchange.
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To further enrich the advice they provide, each Committee maintains several
workgroups that incorporate the perspectives of additional stakeholders from government and
the private sector.
Since the creation of the Committees, their members and their many
working groups have dedicated their time to meeting an average of once every other day for
the past three years.
webcasts.
We make each Committee's meetings publicly available through live
These Committees have informed the development and implementation of all of
HITECH initiatives.
Progress on HITECH Implementation

Our goal is to assist clinicians and hospitals in using technology to meaningfully deliver
health care that is higher quality, safer, patient-centered, and coordinated.
And, we want
providers to thrive in the new health care marketplace that puts a premium on value over
volume, on coordination over fragmentation, and on patient-centered ness over all.
The CMS Medicare and Medicaid EHR Incentive Programs, the ONC-Ied certification
program for electronic health records, as well as the hands-on technical assistance provided by
the Regional Extension Centers (RECs) across the country, are critical in facilitating
unprecedented progress in EHR development, adoption and use.
There are over 1,700 unique
certified products produced by nearly a thousand developers, and certified by one of five
ONC-accredited private sector certification bodies.
As of February 2013, more than 230,000
providers -- nearly 43 percent of the nation's eligible professionals, and over 75 percent of
eligible hospitals -- have earned over $12.6 billion in total payments for meeting the
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ONe's Regional Extension Centers (RECs) have

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28
signed up more than 130,000 primary care providers in over 30,000 different practices.
This
means that roughly 44% of the nation's primary care providers have committed to
meaningfully using EHRs by partnering with their local REC.
RECs have signed up more than
20,000 Nurse Practitioners (NPs), 48% of all NPs nationwide, to assist them in meaningfully
More than 80% of all Federally Qualified Health Center grantees are enrolled
using EHRs.
with an REC.
Health IT Patient Safety Action and Surveillance Plan

The Institute of Medicine's (10M's) 1999 landmark report To Err is Human raised
awareness of the large number of avoidable medical errors harming patients.
The report
also stated that the use of information technology could improve patient safety through
automated order entry, clinical reminders, and drug drug interaction and drug allergy
checking.
While the magnitude of establishing a national infrastructure was hard to imagine
in 1999, the Medicare and Medicaid EHR Incentive Program is a realization of that goal.
Health IT - which includes EHRs and health information exchange - has already demonstrated
the ability to reduce medical errors. For example, EHRs can flag and help providers avoid
potential drug-drug interactions and improve the accuracy of physicians' drug ordering.
Yet
health IT will only fulfill its enormous potential to improve patient safety if the risks
associated with its use are identified, if there is a coordinated effort to mitigate those risks,
and if it is actually used to make care safer.
Recognizing the need to understand how health IT can promote patient safety as well
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as identify and mitigate risks, ONC commissioned an 10M study to determine how
government and the private sector working collaboratively can maximize the safety of health
IT-assisted care.
The 10M report, Health IT and Patient Safety: Building Safer Systems for
Better Care, was published in November 201l.

The 10M Report included the following three key findings:
Health IT can improve patient safety in some areas such as medication safety;
however, there are significant gaps in the literature regarding how health IT
impacts patient safety overall;
Safer implementation and use begins with viewing health IT as part of the larger
sociotechnical system;
All stakeholders need to work together to improve patient safety.
Based on these findings, the 10M recommended that the market forces are not
adequately addressing the potential risks associated with the use of health IT and all
stakeholders must coordinate efforts to identify and understand patient safety associated
with health IT.
Building on 10M's recommendations, ONC worked collaboratively with colleagues

throughout HHS to develop the Health IT Patient Safety Action and Surveillance Plan, the
draft of which was released on December 21,2012.
This Health IT Safety Plan addresses the
role of health IT within HHS' commitment to patient safety.
The plan seeks to build upon
and strengthen patient safety efforts across government programs and in the private sectorincluding efforts by patients, health care providers, technology companies, and health care
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oversight bodies - to improve knowledge on health IT-related patient safety events.
The draft plan prescribes actions that all stakeholders can take within their existing
authorities and resources to promote a culture of safety related to health IT.
Suggested
actions include:
Use ONC-Authorized Testing and Certification Bodies to collect complaints and

conduct surveillance;
Work with developers to establish a code of conduct that includes working with
Patient Safety Organizations and supporting providers in reporting adverse events;
Work with Patient Safety Organizations according to the Agency for Healthcare
Research and Quality's (AHRQ's) Common Formats in order to improve aggregation
and analysis of reported events;
Include safety requirements related to user-centered design, quality management

systems, and easier reporting of adverse events in ONC regulations;
Work with CMS to train surveyors and use health IT to assist investigations;
ONC received public comments on the draft plan through February 4, 2013, and those
comments have been generally favorable.
We are in the process of reviewing comments
and will publish the final Health IT Safety Plan in the near future.
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Consumers - The Most Underutilized Resource in Healthcare

Over the past few decades, we have seen information technology improve the
consumer experience in almost every other aspect of our lives, including the way we manage
our finances, shop, and book travel.
technology.
But, health care has been slower to leverage this
Most notably, relevant information is not available to patients when and where it
is needed.
Increasingly, people are literally taking their health into their own hands-whether that
means tracking their health through a Smartphone app or a remote monitor, participating in
online patient or caregiver communities, or accessing their medical records online.
Changes in
consumer technology, such as the growth of mobile phones, are helping to drive this change -nearly nine out of ten people own a mobile device and nearly half of all Americans own a
smartphone. 2
Mobile devices offers several advantages over traditional PCs-they can help
remove traditional barriers such as geography and time, breaking down the digital divide in
underserved communities, enabling remote treatment, and more continuous monitoring of
health make health more convenient and personalized.
The mobile devices in our pocket can
help us access a world of information at the right time to help make the right health decisions,
which is important since 80% of Internet users have gone online seeking health information.
Apps like iTriage can help us find a local care facility and Pillbox can help us quickly identify
unlabeled medications.
iBlueButton - developed pursuant to an HHS-sponsored challenge
'Pew: http://pewinternet.org/Reports/2012/Cell-lnternet-Use-2012/Main-Findings/Cell-Internet-Use.aspx
3
Pew: http://www ,pewinternet,org/Reports/20 11/Hea Ith Tcpics,aspx).
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program - can help us share our medical history, and Ginger.io tracks our level of activity.
The
Department of Defense has developed apps to help veterans and their caregivers cope with
post-traumatic stress disorder.
Mobile phones can be an incredible tool for empowering
consumers to take control of their health, their care, and their health care finances and as we
know from the literature, more engaged consumers get better outcomes.
ONe's strategy in consumer eHealth is to work with partners to increase patients' ability
to access their own health data, to increase the use of this data for actionable apps and
services, and to shift attitudes around patient empowerment.
ONe is also encouraging institutions that have health data to make it easier for patients
to get easy, electronic access to their data and to use that information in ways that improve
their health and health care.
The Blue Button Pledge Program is a voluntary mechanism for
supporting consumers' access to their health data.
The Blue Button Pledge Program now
includes more than 450 organizations that are committed to learning and collaborating in
efforts to increase patient access to, and use of, health data.
The Pledge Program, launched in
2011, includes "data holders"-such as health care providers and insurers-who pledge to
improve the accessibility of health data to patients and other authorized users, and "non-data
holders" -such as software developers and consumer advocacy organizations- who pledge to
educate consumers about the value of getting and using their health data.
The government is moving forward in this direction.
Veterans today can access their
full records online, and download their records with a simple click of a "Blue Button" - and more
Medicare beneficiaries can access their full Medicare
records online today, and download three years of claims data.

10
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HH5 is also encouraging
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33
Medicare Advantage plans to expand the use of Blue Button to provide beneficiaries with
one-click secure access to their health information.
And the Federal Employee Health Benefits
program has asked carriers to do the same.

Our regulations and guidance are also encouraging this "data liberation" to patients and
consumers. Our partners in HHS's Office for Civil Rights (OCR) recently launched a campaign to
build public awareness of individuals' legal right under the Health Insurance Portability and
Accountability Act of 1996 Privacy Rule to access their own health information - including an
electronic form - if the information is readily producible in the form.
In May 2012, OCR
released a memo detailing these rights and directing consumers to educational resources.
Meaningful Use Stage 2, as part of the Medicare and Medicaid EHR Incentives Programs,
requires eligible providers to use secure e-mail with patients and to provide patients with a way
to view, download, and transmit their own health information.
Under Stage 2, patients will be
able not only to view their health information online, but also to export their data from EHRs in
structured and human-readable formats; share those data with others; and use tools and
applications to store, analyze, or otherwise make use of their information.
Stage 2 also
establishes thresholds for the proportion of patients using these functions, which will
encourage providers to promote their use.
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34
Privacy and Security of Mobile Technology (including Mobile Applications)
At ONC, we recognize that clinicians want to use mobile technology to access and
transmit health information in health care delivery.
We recognize the mobile device benefits
- portability, size, and convenience in overall care coordination.

However, we recognize that there are risks as well as benefits to any technology.
The use of
mobile health technology holds great promise in improving health and health care.
But the
ubiquity and connectedness of mobile devices creates concerns for privacy and security.
ONC
has developed a number of projects that address the privacy and security of mobile health
(mHealth) devices, including convening stakeholders and focus groups to identify concerns and
developing technical assistance and education materials to begin to address those concerns.
First, ONC is working with other agencies and stakeholders to identify security issues
with regard to mHealth technology, including smartphones, implantable medical devices, and
remote monitoring devices.
As part of this assessment, ONC hosted the public Mobile Device
Roundtable in March 2012 where we gathered public, industry, health care provider, and
subject matter expert input on the topiC of safeguarding health information when using mobile
technology.4
The Roundtable included participants from various federal bodies that have a
role in mobile health, including the Food and Drug Administration (FDA), the Federal
Communications Commission (FCC), FTC, and OCR, to discuss the current privacy and security
For more information about the Mobile Device Roundtable, please visit:
http://www.healthit.gov!policy-researchers-implementers!mobile:devices-roundtable-safeguarding-health-inform
ation
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legal framework for mobile devices accessing, storing, and transmitting health information.
In
addition, through its mHealth Privacy and Security Consumer Research Initiative, ONC identified
and explored consumer attitudes and preferences, including underserved populations and
different age categories, regarding the privacy and security of communicating health
information using mobile devices, including the use of mobile apps.
The research initiative
highlights the important role that technology developers can play in meeting consumer needs
for functionality and improving privacy and security.
Results from the initiative may help
inform future policy and educational development activities.

Second, based on these assessments, ONC has developed technical assistance materials
on privacy and security involving mobile technology.
For example, in December 2012, ONC
and OCR rolled out a national, multi-prong privacy and security educational initiative targeted
at health care providers and professionals using mobile devices such as laptops, tablets, and
smart phones in the delivery of care.
We developed a set of online tools that encourage
health care providers and professionals to know the risks and take the steps to protect and
secure health information when using mobile devices.
https://www.healthIT.gov!mobiledevices.
These materials are available at
Although the materials were developed with
health care providers in mind, anyone can use the education materials to help them securely
adopt and harness the power of these technologies.
Through these projects, ONC has been able to rapidly assess and respond to the growing
6 A variety of resources, including videos, fact sheets, and other downloadable resources, addressing the privacy
and security protections and safeguards can be found here: http://www.healthit.gov/mobiledevices
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need for privacy and security policy and guidelines in securing health information as it is being
stored and transmitted through mobile technology.
Model Personal Health Record Privacy Notice
As personal health information increasingly becomes stored managed by companies

that offer direct-to-consumer technologies, it becomes important for consumers to be aware of
these companies' data practices, and to have an easy way to compare the data practices of two
or more companies.
The Personal Health Record (PHR) Model Privacy Notice is designed to be a

standardized template that a web-based PHR company can use to succinctly inform consumers
about its privacy and security policies
The PHR Model Notice was developed by ONC based
on consumer testing that identified key issues individuals care about and language that they
understand.
The PHR Model Privacy Form is meant to be similar to other consumer-oriented
"labels" that have been developed for other industries, such as the nutrition facts label for food,
and the Model Privacy Notice developed for the financial services industry for compliance with
the Gramm-leach Bliley Act.
It is intended to focus only on some important information and
does not substitute for more comprehensive privacy policies.
Many of the largest PHR
companies have agreed to use the PHR Privacy Model Notice.
ONC does not enforce use of
the tool. However, if a PHR company under the jurisdiction of the Federal Trade Commission
7
http://www.healthit.gov/policy-researchers-implementers!personal-health-record-phr-model-privacy-notice
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(FTC) does not adhere to the privacy and security commitments stated in their PHR Notice, the
FTC has the authority to challenge the notices as false or misleading in violation of the Federal
Trade Commission Act.
FDASIA Workgroup on Risk-Based Regulatory Framework for Health IT

Throughout the development of the Health IT Patient Safety Action and Surveillance Plan,
ONC worked collaboratively with other federal agencies such as the Agency for Healthcare
Research and Quality (AHRQ), CMS, FDA, and FCC to leverage existing authorities and to add a
focus on health IT and patient safety.
On February 20, ONC, FDA, and FCC announced the
formation of the Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup under ONe's Health IT Policy Committee -- to provide expert for the development of a
Congressionally-mandated report on an appropriate, risk-based regulatory framework
pertaining to health IT, including mobile medical applications, that promotes innovation,
protects patient safety, and avoids regulatory duplication.
FDASIA indicated that if a
For a more complete explanation of how the voluntary adoption of privacy and security practices can result in
legally enforceable commitments, see The White House, Consumer Data Privacy in a Networked World:
Framework for Protecting Privacy and Promoting Innovation in a Global Digital Economy, Feb. 2012, available at
http://www.whitehouse.gov/sites!default!files!privacy-final.pdf.
In addition, the National Telecommunications
and Information Administration is convening stakeholders to develop a code of conduct to improve transparency
in how mobile applications collect, store, and use personal data.
See
https://www.ntia.doc.gov!other-publication!2013!privacy-multistakehalder-process-mobile-application-transpare
L!fY.
9
Section 618 of the 2012 FDASIA charges the Secretary of Health and Human Services (the Secretary) (acting
through the Commissioner of the Food and Drug Administration (i.e., FDA), in consultation with the National
Coordinator for Health Information Technology (i.e., ONe) and the Chairman of the Federal Communications
Commission (i.e., FCC) to publish a report by January 2014 that expresses "a proposed strategy and
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workgroup was formed, it should be geographically diverse and include representatives of

patients, consumers, health care providers, startup companies, health plans or other
third-party payers, venture capital investors, information technology vendors, health
information technology vendors, small businesses, purchasers, employers, and other
stakeholders with relevant experience.
The three agencies received applications through
March 8th to participate in the Workgroup and are now in the process of reviewing the
The first meeting of the workgroup is expected to be held in April 2013.
nominations.
The FDASIA Workgroup will build on prior work such as the 10M report, Health IT and Patient
Safety: Building Safer Systems for Better Care and ONe's Health IT Patient Safety Action and
Surveillance Plan; FDA's mobile medical applications guidance
Systems Rule
11
10
and Medical Device Data
FCC's National Broadband plan and other relevant work.
Specifically the three
agencies will seek input on issues relevant to the report:

Types of risk that may be posed by health IT which impact patient safety, the likelihood
that these risks will be realized, and the impact of these considerations on a risk-based
approach;
recommendations on an appropriate, risk-based regulatory framework pertaining to health information

technology including mobile medical applications. that promotes innovation, protects patient safety, and avoids
regulatory duplication."
10
FDA's proposed oversight approach would limit FDA oversight of mobile medical apps to the small subset that
are either used as an accessory to a regulated medical device, or that transform a mobile platform into a regulated
medical device.
11
This is a down classification rule (Class I) that does not require premarket submissions for medical products that
are intended to be used in diagnosing, curing treating of a disease and that transfer, store, convert formats, and
display medical device data.
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Factors or approaches that could be included in a risk-based regulatory approach for

health IT to promote innovation and protect patient safety; and
Approaches to avoid duplicative or overlapping regulatory requirements.
Like all ONC FACA Workgroups, all FDASIA Workgroup meetings and documents discussed at
the meetings will be publicly available and will offer opportunities for public comments.
Conclusion
New technologies
including health IT and mobile applications - offer great promise to
improve the quality of care and bring down health care costs.
these goals has been steady and deliberate.
Our progress in moving towards
Working within an open and transparent process
with our public and private stakeholders, we have developed a health IT patient safety and
surveillance report.
We have worked with other government agencies to help secure the privacy of mobile
applications, within existing authorities whenever possible.
As technologies continue to
advance, we want to work together with Congress to ensure health data is secure.
To truly transform delivery, health care providers must also redesign and reengineer
workflow of care.
This does not happen overnight.
Health IT holds tremendous promise for
delivering "smart health" to patients right at their fingertips to help all of us achieve the best
possible outcome for each individual.
We must carefully balance the need for the widest
innovation possible, with protection of patient privacy, security, and safety.
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We look forward to continuing to working with Congress to accomplish these goals.

would be happy to answer any questions that you may have regarding my testimony.
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41
Mr. BURGESS. I thank the gentleman for his testimony.
Before we start members questioning, I do want to stress the importance of the members questions and the importance of getting
direct answers from all of you all. The importance of this questioning is reflected in the fact that the Committee recently changed
rules to limit member opening statements to provide more time for
testimony and questioning. In order to make the question-and-answer period as productive as possible, I ask that you answer the
questions in as a director manner as possible. Some members will
ask yes-or-no questions and I ask that you limit yourself to a yesor-no answer. I thank you in advance for your understanding.
I will now yield myself 5 minutes for the purposes of questions.
Ms. DEGETTE. That is not part of the rules.
Mr. BUTTERFIELD. Will the chairman allow a question at this
point? Is that part of our committee rules?
Mr. BURGESS. Stop the clock.
Mr. BUTTERFIELD. Yes.
Mr. BURGESS. Yes, the committee rules as adopted and the Committee was to limit the opening statements.
Mr. BUTTERFIELD. Dr. Burgess
Ms. DEGETTE. Yes, but not the whole rest of the stuff you said.
Mr. BUTTERFIELD. Dr. Burgess, I have been in this Congress for
812 yearsnot as long as you havebut I have never, ever, ever
heard of a rule such as that.
Ms. DEGETTE. It is not a rule.
Mr. BUTTERFIELD. Thank you.
Mr. BURGESS. Well, let me direct it as a courtesy then to the
members of the committee that we keep our answers direct and to
the questions at hand.
I yield myself 5 minutes for questions.
Now, we are here today of course to discuss the issue of the guidance that was produced in July of 2011. Ms. Foreman, the FDA
proposed its mobile medical apps policy would not regulate the sale
of the general consumer or the use of smartphones or tablets. And
certainly, today, we thank you for the certainty. Will the Final
Guidance definitively say that the sale or general consumer use of
smartphones or tablets will not be regulated by the Food and Drug
Administration?
Ms. FOREMAN. No, it is not the Agencys intent to change that
position in the Final Guidance.
Mr. BURGESS. But, as everything, there is that possibility. And
that is where the uncertainty comes from. And really, one of the
things that the last 2 days and today are all about is trying to provide some certainty for the people who work into this space and are
making significant investments of dollars and time, and they are
doing so because they think they have ideas that are ultimately
going to help people. And we would like to provide them that certainty. I think that is one of the reasons these committee hearings
have been so important.
Some of the uncertainty we have heard this week relates to the
fact that the Guidance issued in July of 2011 is a draft. When can
we look for the final draft, the Final Guidance? When can that be
released?
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Ms. FOREMAN. We have prioritized that Guidance for publication
this year. It should be coming soon with the intent of providing
clarity to the
Mr. BURGESS. Is your microphone working?
Ms. FOREMAN. It is on.
Mr. BURGESS. OK. Pull it a little closer then.
Ms. FOREMAN. We intend to finalize that Guidance this year. It
is a priority for the Agency. It should be coming out within the
next few months. And the point of the Final Guidance will be to
seek to provide clarity by addressing the questions received during
the comment period, and provide additional examples to clarify the
Agencys policy.
Mr. BURGESS. Did you say it will be coming out in the final
month of this year?
Ms. FOREMAN. No, it will be coming out in the coming months.
Mr. BURGESS. In the coming months. And when you say this
year, you are talking about the calendar year and not the fiscal
year?
Ms. FOREMAN. It should be out before the end of the fiscal year,
yes.
Mr. BURGESS. OK. The fiscal year. Well, then lets make a note
of that.
Some of the statements made by the FDA either in the Guidance
or were made by you today, is the Guidance going to be binding
on the Food and Drug Administration? Are there situations where
the Food and Drug Administration has deviated from its Guidance
when exercising its enforcement discretion?
Ms. FOREMAN. Guidance is not binding. Guidance represents
agency thinking, but it is not a regulation. It is not statute. It is
on a lower level that represents agency thinking to provide clarity
both to staff and to industry.
Mr. BURGESS. And again, I do want to just for the record thank
you for your rapid response to that letter. Again, I do hope that
sets a new standard for the Administration in replying to letters
from this committee. Historically, it can take some time to get
questions answered, but these are important questions. These are
questions not asked in a partisan manner in any way, shape, or
form, and really trying to advance the science of the knowledge.
Dr. Mostashari, I will tell you, again, I do get to travel to a lot
of places in the country. I talked to a lot of provider groups. And
I will just say there is some concern. You know, the FDA always
looks to whether things are safe and effective, well, with the exception of tobacco, but always looks to whether things are safe and effective under its regulatory jurisdiction. I cant recall if we ever
saw the randomized clinical trials for electronic health records. Are
those trials in existence? Were they done? Do we have that data?
Dr. MOSTASHARI. Dr. Burgess, thank you for your question.
There are many, many studies that have looked at whether when
you try to improve quality, whether having information helps. And
it is not something that perhaps is well-suited to a randomized
trial at the policy level, but the overwhelming evidenceand we
have commissioned a study ofthat looks at every published study
on thisand while some of the negative studies, the ones that are
counterintuitive, get a lot of press, the preponderance of the evi-
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dence is absolutely that when implemented appropriately, health
IT is going to improve quality, safety, and efficiency.
Mr. BURGESS. And yet, I just noticed from your testimonyI
mean it was the end of last year, December of 2012, when your
safety guidelines were published. Our stimulus bill was passed 4
years ago. The implementation began June of 2011 as I recall, and
December of 2012 is when you were providing the safety guidelines. And you have stipulated such things as privacy and patient
protections.
Dr. MOSTASHARI. We have beenyou know, our belief is that
and I think the evidence is that the best thing we can do for safety
in general is to get off of paper. And the evidence around computerized order entry, for example, reducing medication errors by 48 percent, is clear. And we have seen an increase in e-prescribing that
gets away from my handwriting and perhaps yours, which is a good
thing in terms of improving the safety of prescribing.
We just heard from the Premier System just this week about how
they have saved $9 billion and 91,000 lives by implementing datadriven processes to improve care that cant be done in a paperbased world. So we believe that really getting healthcare into the
data age is critical for improving safety.
Now, as I mentioned, any technology
Mr. BURGESS. Sir, I am actually going to stop you because my
time has expired. In the interest of getting everyone heard, I will
yield to the ranking member of the subcommittee.
Ms. DEGETTE. Thank you, Mr. Chairman.
I just have a few questions. Over the last 2 days of hearings before today there was a lot of testimony and claims that app developers face a threat from the FDA and that the Agency is planning
to regulate mobile phones on a wide range of apps and then impose
a medical device tax on phones. In the chairmans opening statement, I think he implied that he understands that the Agency is
not planning to put the medical device tax on phones, but I just
want to clarify exactly what the Agency is planning to do, Ms.
Foreman. So I want to ask you a couple questions.
Is it within the Agencys jurisdiction to regulate mobile medical
apps?
Ms. FOREMAN. Yes, it is.
Ms. DEGETTE. If you can pull that microphone even closer, I
think you are a very soft-spoken person. Can you give us some examples of the types of apps that the FDA is trying to regulate?
Ms. FOREMAN. The apps that we are trying to regulate and that
we have been regulating for a decade, are similar to what is regulated through other medical device technology, such as a central
monitoring station for a nurse that transmits patient data, heart
rate, SpO2, other critical parameters for patient care that need to
be monitored. We have seen ultrasound technology where there is
an app and a transducer that can plug into a smartphone to allow
ultrasounds to take place. Those are the types of technology that
we are regulating.
Ms. DEGETTE. And why are you trying to regulate those types of
technology, Ms. Foreman?
Ms. FOREMAN. Those types of technology pose patient risk. If the
device does not perform as intended, there is a potential for patient
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risk. Additionally, it is the same as other medical devices we regulate. We regulate based on intended use, not based on platform.
Just because a device moves to a mobile platform, it would not be
the Agencys intention that that would make it deregulated.
Ms. DEGETTE. So you are not looking at how the app is used; you
are looking at what the purpose is, right?
Ms. FOREMAN. Exactly.
Ms. DEGETTE. And this is an ability that the Agency has had for
some years; it is just not new under the Affordable Care Act or
under the stimulus, correct?
Ms. FOREMAN. That is correct. Our first clearance of a mobile app
product goes back to 1997.
Ms. DEGETTE. 1997, oK. And can you tell me what types of apps
the Agency will not be regulating and why?
Ms. FOREMAN. There are apps that do not meet the definition of
a medical device. The Agency would not regulate those. Those
would be, for example, an app that takes an electronic version of
a printed textbook. We have said that is not a medical device.
Ms. DEGETTE. OK.
Ms. FOREMAN. There are mobile medical devices that meets the
definition of a device, but the risk is low. The Agency would rather
focus its regulatory priorities on the higher-risk products. So devices for maintaining a healthy lifestyle that help with
Ms. DEGETTE. Pedometers
Ms. FOREMAN. Exactly. We would not put regulatory oversight
priorities into those products.
Ms. DEGETTE. OK. Now, in a different subcommittee the other
day, members of the industry also agreed with what you are saying. Qualcomms representative testified at that hearing the FDA
is squarely within its jurisdiction and we took a lot of their initial
actions as a very promising indication to the industry at large that
they were willing to work with all of us. So Ms. Foreman, I want
to ask you, what are you doing to make sure that the Agency
doesnt overreach when regulating these devices and using the
standards that you have set forth?
Ms. FOREMAN. As I mentioned, for FDA to regulate the product,
it must first meet the definition of a medical device. That is what
gives the Agency its authority. But for all of the products that technically meet the definition of a medical device, we have narrowed
our focus to a smaller subset of those based on risk. We are actually refining our regulatory approach rather than overreaching.
Ms. DEGETTE. OK. So that is good that you are narrowing it
down, looking at things that affect patient safety and so on, but we
are still hearing concerns about the impact of uncertainty on the
mobile medical device market. Can you tell me what the Agency is
doing to eliminate this uncertainty for investors and developers?
Ms. FOREMAN. We believe finalizing the mobile medical apps
Guidance is the first step in eliminating that uncertainty. That
Guidance will provide clear, transparent, and predictable messaging regarding FDA oversight of mobile medical apps.
Ms. DEGETTE. And that is the Guidance that you told Mr. Burgess that you are planning to issue by the end of the fiscal year,
right?
Ms. FOREMAN. Correct.
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Ms. DEGETTE. Now, also, we have heard concerns about the effects of FDA-induced delays on the mobile medical device market.
Now, how do you respond to those?
Ms. FOREMAN. We looked at our performance over the last 3
years, which we believe is a contemporary sample of performance.
On average, it takes the FDA 67 days to review a mobile medical
app. That is well within our statutory time frame of 90 days for
the 510(k) process. All mobile apps we have seen thus far have
been in the 510(k) process on
Ms. DEGETTE. And you are going to continue that
Ms. FOREMAN. For the most part, yes.
Ms. DEGETTE. Thank you. Mr. Chairman, I had referenced the
letter from the FDA in my opening statement and asked for inclusion in the record, and the chairman said he had received it but
I dont believe he agreed to my unanimous consent request to put
it into the record, so I would renew that request.
Mr. BURGESS. I also received it and I accept your unanimous consent request. So ordered.
[The information appears at the conclusion of the hearing.]
Ms. DEGETTE. Thank you so much.
Mr. BURGESS. The chair recognizes Mr. Johnson from Ohio, 5
minutes, for the purposes of questions, sir.
Mr. JOHNSON. Thanks to our panelists for coming today.
The Meaningful Use Program has made good progress in automating the current system. The first stage was to encourage adoption of current technology and gain automation efficiencies. Of
course, Stage 2 addressed connectivity and sharing of information,
and Stage 3, the final stage, is where providers and patients have
accurate, real-time information in the systems and devices that
provide care anywhere.
As an IT professional myself for nearly 30 years, architecture
and a roadmap of where you are going is vitally important because,
as they say, if you dont know where you are going, any road will
get you there. And you can pump millions, billions into these
projects. And in todays environment, our healthcare providers simply dont have millions and billions to pump into something that
is not working for them.
So what is the gap between todays technology and the architecture of tomorrow to achieve an integrated, coordinated care system? How are we making sure that the data that is being collected
people can use? I call it decisional information. How are we making
sure that we are connecting the dots?
Dr. MOSTASHARI. That is a terrific question and you are absolutely right that it is the use of data not just the data itself that
improves care. And as we found in other IT endeavors, itparticularlyIT becomes particularly important when you redesign the
processes to take advantage of the information technology instead
of merely digitizing the paper-based or former processes.
Mr. JOHNSON. And I would certainly agree with you. You know,
over my 30 years in IT, one of the cardinal lessons is just because
something can be automated doesnt mean that it should be automated. It is an issue of business process reengineering, and if you
dont do that, you dont have a complete solution or certainly you
dont have a solution that is connected.
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So who is developing the architecture that tells our healthcare
providers in our system how this is all going to fit together?
Dr. MOSTASHARI. We have developed that roadmap that you
speak of, and it is an incremental roadmap, as you mentioned,
through the stages. And it begins with making sure that we have
data because until you have data, you really cant see what you are
doing. You cant have accountable care if you cant count. And that
is where paper-based systems are today. So in Stage 1, the idea is
lets collect the information in a structured way becauseyes.
Mr. JOHNSON. Well, that goes back to what I said earlier, and I
think this is a discussion between two IT professionals here that
everybody else may get bored with. That goes back to the if you
dont know where you are going, any road will get you there. I
dont think you know what data you need until you have an architecture and you know what the end stage looks like. You know, in
the many, many software and technology programs that I managed
throughout my 30-year career, if you dont start with an idea of
what the end state looks like, then you waste a lot of money; you
waste a lot of time.
Dr. MOSTASHARI. That is right.
Mr. JOHNSON. So I am not sure data collection up front without
knowing what data you want to collect makes a whole lot of sense.
Dr. MOSTASHARI. Let me clarify my response.
Mr. JOHNSON. Sure. Because we start with data. Data doesnt become information until it is relevant and until it can be used. And
data just for the sake of data, as you know, is
Dr. MOSTASHARI. That is right.
Mr. JOHNSON. So go ahead. I am sorry.
Dr. MOSTASHARI. Sorry about that. So we start within the
framework, we actually start with the end in mind. So we said
what is it about the use of technology that canwe can expect to
improve safety, improve the quality of care, patient engagement,
public health. And then we work backwards to say, oK, if we want
to reduce deathsunnecessary deaths, those are associated with
better decision support at the point of care, it is associated with
quality measurement, and being able to make a list of patients by
certain criteria, oK, and taking that a step back, you need to be
able to have a list of medications for patients. That is pretty clear.
We need to have a list of their problems and diagnoses. You need
to know their allergies. You need to know their laboratory values.
You need to know their blood pressure and smoking status. And it
was those data elements recognizing that as the system evolves,
there would need to be flexibility and the ability to extend that
framework and add in the next iteration devices, for example.
Mr. JOHNSON. Like I said, people are probably going to get bored.
You and I can
Dr. MOSTASHARI. We would
Mr. JOHNSON. But how many physicians have been involved in
the development of this roadmap and the kind of data that we need
to
Dr. MOSTASHARI. We have one of the, I think, hardest-working
and most respected Federal Advisory Committees in government.
Weitthereit isthere are certain statutory representations
on that. The house majority and minority leaders appoint members
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to the Policy Committee. The Senate minority, majority leaders,
the Comptroller General
Mr. JOHNSON. My time is expired.
Dr. MOSTASHARI. Sorry.
Mr. JOHNSON. The chairman is making that known, so I thank
you for your answers. I would love to talk to you more sometime.
Mr. BURGESS. And the gentleman may request the answer in
writing, and I hope that he will.
The chair recognizes
Dr. MOSTASHARI. Will do.
Mr. BURGESS [continuing]. Now Mr. Waxman, the ranking member of the full committee.
Mr. WAXMAN. Thank you, Mr. Chairman.
Ms. Foreman, we have heard a lot of allegations over the last few
days that FDA is intending to regulate everything and anything
digital or online that has any relation to healthcare. But the facts
seem to be very different. I know you have attempted in your testimony, as well as in the 2011 Draft Guidance, to allay concerns
about the scope of what FDA intends to regulate. But I would like
for the record to go over some of the examples we heard in testimony yesterday or the day before. Is FDA currently proposing or
does it intend in the future to regulate ordinary smartphones and
tablets?
Ms. FOREMAN. No, it does not.
Mr. WAXMAN. What about mobile platforms in general such as
the iPhone, Blackberry, Android phones, tablet computers, or other
computers that are typically used as smartphones or personal digital assistants?
Ms. FOREMAN. No.
Mr. WAXMAN. What about the entire mobile network?
Ms. FOREMAN. No.
Mr. WAXMAN. Each new mobile device released on the market?
Ms. FOREMAN. No.
Mr. WAXMAN. All health IT?
Ms. FOREMAN. No.
Mr. WAXMAN. An iPad application to help track the number of
steps walked per day?
Ms. FOREMAN. No.
Mr. WAXMAN. An iPad application that reminds one that it is
time to refill a prescription?
Ms. FOREMAN. No.
Mr. WAXMAN. Software that enables a physician to search a medical textbook?
Ms. FOREMAN. No.
Mr. WAXMAN. Apps to allow parents to access online services
such as personal health records to document procedures that a
baby has undergone and drugs their baby was given?
Ms. FOREMAN. No.
Mr. WAXMAN. I dont think you can be any clearer. FDA has established limits on what it can and cannot regulate in the mobile
device market, and I appreciate you walking through these limits.
While I know that IRS, not FDA, implements the tax code, I
would like to ask you a bit about the recent claims that mobile
platforms will be taxed under the Medical Device Act. Under the
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new medical device tax, will smartphones and iPads now be taxed
as medical devices?
Ms. FOREMAN. The FDA is a public health agency, not a taxation
agency.
Mr. WAXMAN. I understand.
Ms. FOREMAN. These questions would probably be best answered
by IRS or the Treasury, but my understanding is no.
Mr. WAXMAN. These type of products are exempt from the medical device tax, isnt that correct? Can you explain a little bit about
this exemption?
Ms. FOREMAN. As I said, we are public health agency
Mr. WAXMAN. Yes.
Ms. FOREMAN [continuing]. Not a taxation agency, but they
would not be regulated as medical devices, therefore, not subject to
the medical device tax.
Mr. WAXMAN. OK. As I understand it, they will be exempt because FDA will not define them as a medical device, and even if
you did define them as a medical device, they wont be tax because
they will qualify for the retail exemption. The law says that items
sold to consumers by way of retail cannot be taxed. Isnt that your
understanding as well?
Ms. FOREMAN. That is my understanding.
Mr. WAXMAN. Although we dont rely on you for tax information.
Ms. FOREMAN. You really should not.
Mr. WAXMAN. But we are interested in this issue because it has
been brought up so many times, and this committee is not a committee that has jurisdiction over tax.
I thank you very much. It is clear that fears that iPhones and
other smartphones are going to be regulated by FDA and taxed as
medical devices are unfounded and we can put this myth to rest.
OK. Well, Mr. Chairman, my staff informs me the next question
is not for me to pursue and I have asked the questions that I think
are important and I think they are good way to end the third day
of hearings to allay a lot of the fears that have been raised in the
other two. And so unless anybody wants my minute, I will yield it
back.
Mr. BURGESS. And the chair thanks the ranking member. It is
forever in his debt.
Now yields for 5 minutes to Ms. Ellmers from North Carolina.
Mrs. ELLMERS. Thank you, Mr. Chairman.
Thank you. Thank you. And Dr. Mostashari, good to see you
again. We have worked together many times on this issue and
there again thank you for coming. Thank both of you for coming
to testify today.
You know, one of the thingsand I know we have discussed this
in the pastis really the cost to physicians who are small business
owners, and as important as we all know health information technology is, the cost being passed on to them, you know, there are
estimations of 15,000 to $70,000 for the cost of implementing IT.
And also, there is the issue of the physician really being taken
away from the patient at the bedside to implement the information.
And there is of course that learning curve that everyone has to go
under.
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Now, one of the points that is being made is how this is helping
eliminate errors and actually thereby improving healthcare. However, when limited time is given to the patient directly, hands-on,
and eye-to-eye contact with that patient, dont you think that subsequently it could actually have a bearing on the ultimate outcome
of the patient, maybe something being missed, possibly tests being
over-ordered as a result of not an adequate time with the patient?
Dr. MOSTASHARI. Overall, thewe actually have data from the
National Center for Health Statistics where providers report that
EHRs have, in their estimation, produced clinical benefit for their
patients. It is 79 percent. And if you look at those who are using
the modern systems and who have been using it for more than 2
yearsand this is important because it takes time
Mrs. ELLMERS. Yes. Yes. Sure. Sure.
Dr. MOSTASHARI [continuing]. To get used to the systems, that
rises to 92 percent. Now, providers believe that in their practice the
electronic health records are providing clinical benefit to their patients.
Mrs. ELLMERS. OK. Now, that leads me to my next question because a lot of the software is incompatible with other facilities, so
software that one physician may be using may not be the same
software another physician or the physician in the hospital not
using the same. So getting back to again considering errors, considering the possibility of information not being exchanged adequately, but also considering cost, which of course ultimately gets
passed on to the patient, and we are always looking for good quality of care, what is going to happen when we are trying to integrate
all those systems? Is this cost then going to be passed on to the
physician again and, you know, having to bear the brunt of that
expense?
Dr. MOSTASHARI. Making sure that the patient information is
available when and where it is needed is one of our top priorities.
And we could have, as some countries have done, have said we are
going to solve that problem by the government is going to buy the
EHR system for the whole country. That is not the way we do
things
Mrs. ELLMERS. Yes. Yes.
Dr. MOSTASHARI [continuing]. Right? We said the people who are
best suited to make those purchasing decisions are the hospitals
and doctors who have to live with the systems. But in order to
make sure that they can talk with each other, then we need to
have some standards. We need to have a certification program and
to evolve that certification program and to create consensus, industry consensus
Mrs. ELLMERS. Yes.
Dr. MOSTASHARI [continuing]. Private sector consensus around
how we can have one doctor choosing one system, the other choosing a different system that meets their needs but having those systems
Mrs. ELLMERS. Be able to communicate.
Dr. MOSTASHARI [continuing]. Be able to talk to each other. That
is the approach we have taken, and the certification criteria for
2014 put a big step up in those requirements.
Mrs. ELLMERS. OK. Thank you.
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Ms. Foreman, I do have a couple questions. I know we continuously are talking about, one, the FDA regulation issue, which is
very important, but also the tax on the medical devices. Has the
FDA looked at this as an issue that it might actually be stifling
some of the innovation moving forward with having the tax on
medical devices?
Ms. FOREMAN. As I said, we are public health agency. Our decisions are governed by public health. Our decision-making is based
on balancing innovation and public health.
Ms. FOREMAN. We identified a large subset of devices that could
be under enforcement discretion without our regulatory oversight.
Ms. FOREMAN. As it happens, those devices may not be subject
to the device tax.
Mrs. ELLMERS. OK.
Ms. FOREMAN. As was mentioned, there is a retail exemption as
well
Mrs. ELLMERS. Right.
Ms. FOREMAN [continuing]. Meaning products available for retaileven declared to be a medical deviceis exempt from the
taxFDA does is a public health organization, not a taxation agency.
Mrs. ELLMERS. Thank you. Thank you. My time is expired.
Thank you both.
Mr. BURGESS. The chair recognizes the gentleman from North
Carolina 5 minutes for purposes of questions, sir.
Mr. BUTTERFIELD. I thank you, Mr. Chairman.
And I thank both of you for your testimony here today.
Over the course of the last 2 days of hearings, and actually in
Ms. Foremans testimony here today, we have learned that FDA
has proposed regulating only a very small subset of mobile applications. FDAs Draft Guidance states that the Agency will only look
at those mobile apps that are essentially acting as a medical device
or as part of one. The Guidance also explicitly exempts many of the
apps that my colleagues on the other side have been trying to scare
people into thinking FDA was going to take over, things like electronic PDRs and electronic health records. That seems like a very
reasonable approach to me.
But I want to learn more about exactly what kind of regulatory
burden we are talking about even with this small subset of applications that will be regulated as devices. I know that an FDA-regulated medical device may fall into one of three tiers. We have heard
about that. Class 1 devices are the least risky devices while Class
3 devices are the most risky.
And so let me start with Ms. Foreman. Ms. Foreman, can you
briefly elaborate on these three levels of device oversight and explain what responsibilities a device manufacturer has under each
of these levels?
Ms. FOREMAN. Certainly. I will start at the bottom and work up.
If the device is a Class 1 device, and this small subset could include devices that would meet the Class 1 definition of a medical
device, they are not subject to agency premarket review. They are
subject to meeting registration and listing requirements, as well as
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the quality system regulation, which ensures that the devices are
manufactured properly.
Moving up to Class 2 devices, these must meet those same criteriaregistration, listing, quality systembut they also need
what is called a 510(k) or a premarket notification. That application would allow the Agency to review and clear the device as
equivalent to another device on the market. There is a user fee associated with that. It is just under $5,000. However, if it is a small
business, it is half of that. If the sponsor makes significant modifications to the device, they would need a new 510(k), but as I mentioned, we planned many of those iterative changes to not require
new submissions of 510(k)s.
If we move up to the next level, Class 3, those devices require
a premarket approval application. To date, we have not found a
mobile app that would fit into that category. I am not saying that
in the future it wouldnt be possible, but we have not seen one yet.
Mr. BUTTERFIELD. So essentially, what you are saying is that a
Class 1 or 2 device doesnt have to do all that much in terms of
premarket clearance, while Class 3, if there is one, sounds like it
may be subject to more stringent requirements if one evolves
Mr. BUTTERFIELD [continuing]. Is that correct?
Mr. BUTTERFIELD. OK. Now, which level of regulatory oversight
will most of these medical applications fall under?
Ms. FOREMAN. Class 1 or Class 2.
Mr. BUTTERFIELD. Class 1 or Class 2. And you dont know of any
Class 3 existing at this moment?
Ms. FOREMAN. I do not.
Mr. BUTTERFIELD. All right. Now Ms. Foreman, there were also
some assertions yesterday that FDA lacked the expertise to regulate mobile applications. Your testimony states that you have regulated medical device software for decades and mobile apps for more
than 10 years. Can you elaborate on FDAs experience regulating
in this area?
Ms. FOREMAN. Absolutely. This is not a new area for the FDA.
We have been regulating software and mobile apps for some time.
When we do our review, we actually bring together two different
sets of expertise. There is the software expertise, we have software
engineers who will review the software information to make sure
that it was developed properly, coupled with a clinical review because the app is intended for a medical application. For example,
if you take an app to view a radiology image on a smartphone, the
software reviewer can make sure that all of the technical specifications happen properly on the smartphone. And we will ask the clinical reviewer for an evaluation to determine if, for example, we
view an image on a smartphone, can we actually detect cancer with
the same level of sensitivity and specificity that we would on the
large view station? You can zoom the image, you can pan, you can
look at it that way, but is there a difference between looking at the
whole image versus pieces of the image to make sure that patient
safety is not compromised? Because you dont want somebody to
have undergone radiation for a diagnostic purpose and thenrealize there is a false negative or a false positive.
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Mr. BUTTERFIELD. Can you finally address how you plan to keep
up with the world in which so many apps are already on the market and so many new ones are coming out every day? How are you
going to keep up with all this stuff?
Ms. FOREMAN. As I mentioned, part of keeping up with it is
prioritizing our focus, and we are prioritizing our focus on the
small subset; within that subset we receive about 20 applications
a year. Right now, we are getting less than 20 a year. That is actually in our 510(k) inventory. That is about .5 percent of the medical
device applications that we review. And keeping up with technology
is something that we are always faced with, so that is why we add
on competent staff and we make sure to provide training opportunities for those staff so that they can continue to stay abreast of
the latest technology.
Mr. BUTTERFIELD. Thank you. My time is expired.
Mr. BURGESS. The gentlemans time is expired.
I am advised that votes have been called. We will try to go over
and get through as many of the panel as we can.
I recognize the gentleman from Missouri 5 minutes for questions.
Mr. LONG. Thank you, Mr. Chairman. And thank you all for
being here today.
Director Foreman, I have a question for you. As far as current
FDA Risk Evaluation and Mitigation Strategy, REMS for short,
their Guidance requires, doesnt it, that medication guides upon
first dispensing of the medication and then for every subsequent
refill you have to have the medication guides printed out. Is that
correct?
Ms. FOREMAN. So I am going to apologize because REMS is a
provision implemented by CDER, or Center for Drug Evaluation
and Research. So that is really outside of my area of expertise in
the Center for Devices and Radiological Health.
Mr. LONG. OK. Who should I go to to answer that question? Who
should I
Ms. FOREMAN. CDER is headed by Dr. Janet Woodcock.
Mr. LONG. OK. OK. Because that was my intent was to ask if
on a refill prescription if that could be able to be handled through
a mobile device as opposed to trying to mail a stack of how to retake your medicine every time that it is prescribed. So with that
and I know we are short on timeMr. Chairman, I yield back.
Mr. BURGESS. The gentleman yields back.
The gentleman from New York is recognized for 5 minutes for
questions.
Mr. TONKO. Thank you, Mr. Chair.
Dr. Mostashari, there is a broad consensus that the increased
use of electronic health records and health information technology
ultimately leads to better patient care and a bending of that cost
curve and savings, but there is also a concern that the adoption of
these EHRs also provide an increased opportunity for fraud by exaggerating the intensity of care or severity of patients conditions
on their Medicare claims. We have, I guess, labeled this as up-coding and it is often facilitated by software programs that prompt
billing for additional services that were not provided and maybe
only tangentially related to the care received. Many of our health
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IT vendors are developing these systems to promote their products
as a way to increase the bottom line.
So my question is can you discuss what your office is doing to
develop guidance and technological standards in electronic health
records software that will help to prevent this type of fraud?
Dr. MOSTASHARI. Yes, thank you for the question. I want to make
one thing very clear, which is that if there is documentation of care
that did not occur, that is fraud. And CMS and the Attorney General and the Secretary of Health have made it very clear that we
will not tolerate fraud. And the electronic health records provide
increased tools also on our side to be able to better investigate and
prosecute fraud should it occur. There are always those who will
attempt to defraud the system and I think this Administration in
particular has been very successful and has had record prosecutions and recoveries under that.
But I think your question gets to also issues where it is not explicit fraud, and those are more complicated situations. I think
some of the analysis has been done looked at patterns of coding intensity over the past decade. Before the first meaningful use payment check ever went out, for a decade there has been this creep
towards higher intensity codes. CMSthis is not a new issue for
CMS and they have ways of dealing with shifts in these patterns.
But the electronic health records that were formally predominantly
used for documentation and billing purposes before meaningful use,
that may have been part of the business case for them. I think that
our challenge is twofold. First, to make sure that we get the broadest possible input on ways that we can mitigate any possibility of
the records systems themselves inducing inadvertent violations.
The second is to make sure that the systems meet the needs of
the future, which is, as I think there is broad consensus, means
moving away from paying fee-for-service based on documentation
and more towards outcomes and value.
Mr. TONKO. Thank you. And what lessons can be drawn from the
implementation of EHRs nationwide from the VAs long successful
track record with VISTA, their Veterans Health Information Systems and Technology Architecture program, specifically in terms of
interoperability and usability of records?
Dr. MOSTASHARI. It is interesting, following on your previous
question, one of the groups that had the most experience with the
perils of copy-and-paste was the VA, which, even though there was
no billing incentive, it was convenient to carry forward notes from
before, and it resulted in notit is not a billing issue. It is a clinical documentation issue where it wasnt easy to understand. If you
practiced at the VA, sometimes you saw notes that were copied forward and forward and forward, and it wasnt good for clinical care.
You couldnt understand what was really going on with the patient
in this visit. And the VA has done a lot working with clinical leadership to say how can we improve the quality of the clinical documentation and the usability of the systems?
The VAthere is very strong evidence that they have saved billions of dollars by implementing IT and by continually improving
the systems that they have. And if there is one lesson I would take
from the VA it is that, that no system is perfect the day it is implemented. And it becomes improved over time through the polishing
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54
of that stone to the application of clinical judgment, improved
usability, improved interoperability, and that is what we are engaged with here. This is not a, you know, one-and-done process.
This is going to be a continual process of refinement, optimization,
improvement, and redesign.
Mr. TONKO. Thank you, Dr. Mostashari and Ms. Foreman, for appearing before us.
And Mr. Chair, with that, I yield back.
Mr. BURGESS. The gentlemans time is expired.
The chair now recognizes Mr. Griffith for 5 minutes for questions, sir.
Mr. GRIFFITH. Thank you.
And I apologize to the witnesses in advance. I have to move fairly quickly so I am cutting through a lot of the explanation because
I think you all know where we are heading with the questions as
we get to it. But if you need further, let me know.
Ms. Foreman, your testimony notes that questions about medical
device tax should be directed to the IRS, but clearly, they are going
to need help in figuring out what is a medical device at what you
are regulating as a medical device if it is the purpose of it and not
the platform. And so I would ask, have you had any discussions
with the IRS about this tax, if they have asked for your input on
that?
Ms. FOREMAN. We provided technical input to the IRS on the interpretations of our laws. The way it was implemented is that if
a medical device lists, it would be subject to the tax.
Mr. GRIFFITH. And can you provide us with a copy of what you
gave the IRS so we can take a look at that to the committee? Not
today, but subsequently?
Ms. FOREMAN. I can look into that.
Mr. GRIFFITH. OK. Thank you. And has the FDA done any analysis on the impact of the tax either in dollar figures or the number
of manufacturers it will have an impact on?
Ms. FOREMAN. FDA is a public health agency. We are not involved in the taxation. We receive no direct benefits.
Mr. GRIFFITH. In regard to the questions, the list of examples
that Mr. Waxman listed out, while the FDA does not currently
have any plans, do you believe that the FDA could if it so chose
to do so regulate those examples down the road if it had a change
of heart?
Ms. FOREMAN. If the device meets the definition of a device as
defined in the Food, Drug, and Cosmetic Act, we could. We have
no intent to. The only thing that would change our mind is if there
was a strong safety signal that we became aware of related to a
device that we were not regulating appropriately under enforcement discretion. By not regulating it, that would cause us to reconsider our position. But absent strong safety signals, no, we would
not change our mind.
Mr. GRIFFITH. All right. And then the practical question that I
would have is if somebody is currently developing an app of a medical nature, how does anybody know if they are supposed to be contacting the FDA? And, you know, I am just an old country lawyer
and I got on my tablet hereit is an Androidand found an article
yesterday and there was lots of; I just chose this one because it
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55
sounded interestingthat the iPhone is now a handy tool for detecting and diagnosing parasites, and the article says using little
more than an iPhone, strips of double-sided tape, a cheap ball lens,
and a battery-powered flashlight, a workable model was assembly
to determine whether or not a child had parasites. Are you all regulating that or not?
Ms. FOREMAN. To my knowledge, we have not regulated that. It
has not come before us. A diagnostic device, though, would meet
the definition. That would
Mr. GRIFFITH. So if the Canadians, the Bostonians, and the
Swiss who worked this up to help in other countries decided that
it might be helpful in rural parts of the United States, they would
have to come to you first, and instead of costing $8, it would cost
what? Hundreds of thousands?
Ms. FOREMAN. We are not involved in the pricing of medical devices.
Mr. GRIFFITH. No, no, no, I am not talking about with the price
is. I am talking about how much it costs to get it approved.
Ms. FOREMAN. So, as I say, a 510(k) fee is just under $5,000. If
it is a small business, it would be half of that.
Mr. GRIFFITH. OK.
Ms. FOREMAN. So $2,500.
Mr. GRIFFITH. But you would want all kinds of tests and studies,
not the fact that they have been out in the field and made it work
with double-sided tape, am I not correct?
Ms. FOREMAN. I am not inherently opposed to double-sided tape
but
Mr. GRIFFITH. I understand. I think I have made my point, and
I yield back my time, Mr. Chairman.
Mr. BURGESS. I thank the chair. The chair yields to the gentleman from Texas, Mr. Barton, for questions.
Mr. BARTON. Mr. Chairman, I appreciate the time. I want to
yield it to you to use as you so decide.
Mr. BURGESS. Well, I thank the chairman emeritus.
Dr. Mostashari, I just have to ask you here as we conclude today,
I hear a lot of stuff about interoperability. I mean you are the
head. Why dont you just fix that? Why dont you just make that
happen?
Dr. MOSTASHARI. We are using every lever at our disposal to increase the sharing of information, and that includes not just the
data standards and getting industry together to help us. We dont
want to be the ones to say, you know, we will choose the standards.
We really want to work with industry to get consensus and to accelerate this.
Mr. BURGESS. But, you know, in the interest of time, we do hear
about this a lot. Even anecdotally, hospital systems in the same
city that have the same operating system arent talking to each
other. It seems like you could make that happen.
Dr. MOSTASHARI. Wethe 2014 certification criteria, Dr. Burgess, IweI would be happy to go into great detail with you, but
they are a big step forward, and I believe that hospitals and doctors around the country will see a palpable difference once those
certification criteria are in place.
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Mr. BURGESS. Well, I want to thank both of our witnesses for
being here today and for bearing with us. I apologize about votes
cutting the hearing short. Dr. Mostashari, I look forward to having
you back at either the Health Subcommittee or this subcommittee
in the future. You are a fascinating witness. We have learned a lot
this morning from both of you, and I appreciate your time.
I want to thank the members for their devotion to the hearing
today.
The committee rules provide that members have 10 days to submit additional questions for the record to the witnesses. I also
failed to ask for unanimous consent that all members statements
that wish to be entered in the record be entered.
Hearing no objection, so ordered.
The hearing stands adjourned.
[Whereupon, at 10:25 a.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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57
20993
The Honorable Tim Murphy

Chairman
Subcommittee on Oversight and Investigations
House of Representatives
Washington, D.C. 20515-6115
Dear Mr. Chairman:
Thank you for your letter of March 1,2013, cosib'1led by six of your colleagues, regarding the
requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Patient
Protection and Affordable Care Act (PPACA), and how these laws are applied to the
mannfacturers of smartphones, tablets, and individualized applications (apps). Your letter poses
several specific questions concerning the activities of the Food and Drug Administration (FDA
or the Agency) regarding the regulation of "ire less medical devices (also referred to as "mobile
medical applications" or "mobile medical apI's").
We have restated your questions below in bold, followed by FDA's responses.
1. When will the FDA issue final or updated guidance with respect to the July 19,2011,
request for input on its oversight approach for mobile medical applications designed for
use on smar!phones or other mobile computing devices?
FDA issued a draft guidance domment regarding mobile medical applications on July 21,
That guidance announced FDA's intention to exercise enforcement discretion for
most mobile apps. The draft guidance proposed regulatory oversight of only a small subset
of mobile apI's (referred to in the guidancc as "mobile medical apps') that meet the definition
ofa device in section 201 (h) ofthe FD&C Aet and are intended for use as either: (1) an
accessory to a regulated medica~ de\'ice, or (2) to transfom1 a mobile platform ioto a
regulated medical device.
2011.'
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and Food and Drug Administration Staff - Mobile Medical
58
Page 2 - The Honorable Tim Murphy
FDA received more than 130 submissions to the public docket on the draft guidance. Many
cornmenters sought additional clarity on the types of mobile apps for which FDA intends to
exercise enforcement discretion. FDA will seek to provide this clarity in the final guidance.
Commenters ovenvhelmingly supported the narrowly tailored approach FDA described in the
draft guidance. FDA has since received many more inquiries from members of industry
eager to see the guidance finalized. The mobile medical apps guidance is currently in the
final stages of Agency review. The Agency has previously indicated its intent to publish the
final guidance this year.
2. Has the FDA discussed, prepared, or analyzed the effect of the medical device tax on
smartphones (as well as tablets or similar devices) or the creators or distributors of
applications for those products? If so, please provide all documents analyzing or
relating to this issue.
FDA has not analyzed the effect of the medical device tax on creators and distributors of
smartphones, tablets, and similar devices but is aware of concerns about the effect on
innovation if novel technologies become subject to the tax. FDA developed the Agency' S
draft mobile medical apps policy to protect public health and promote innovation,
Although the definition of a "taxable medical device" is tied to the FD&C Act, it is the
Internal Revenue Service (IRS) and the Department of the Treasury that are responsible for
the excise tax imposed on the sale of certain medical devices, not FDA. Moreover, as
indicated by the IRS's definition of "taxable medical device," not all medical devices
regulated by the FD&C Act are subject to the ta'{-{)nly those that are required to list with
FDA. Because the mobile medical app draft guidance states that the Agency intends to
exercise enforcement discrction for many mobile apps v,1th respect to applicable device
requirements, including listing, FDA does not expect those devices to list.
Questions about the implementation of this policy should be directed to the IRS.
3. Will the actual use of a smartphone, tablet, or app be a factor in whether the FDA
chooses to regulate the device or app as a medical device? Has it been a factor in any
analysis by FDA already completed?
The answer to both questions is no.

As stated in FDA's draft mobile medical apps guidance, FDA's mobile medical apps policy
will not regulate the sale or general consumer use of smartphoncs, or tablets even when such
sale or use is in a health care setting (e.g., in a doctor's ofilce or hospital). FDA's proposed
mobile medical apps policy does not consider entities that exclusively distribute mobile
medical apps, such as the owners and operators of "iTunes store" and"Android market," to
be medical dcvice manufacturers.
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Instead, FDA's draft mobile medical apps guidance toeuses on the intended use ofthe mobile
app and proposes oversight only for those mobile apps that meet the definition of a "device"
59
Page 3
under section 201 (h) ofthe FD&C Act, and are either intended for use as an accessory to a
regulated medical device or to transform a mobile platform into a regulated medical device.
This analysis is typieal of how FDA has handled various products that might be devices that
serve multiple purposes. FDA looks to the intended use of the product to determine whether
the product is a device. The intended use of a product is typically detennined by how a
product is marketed; that is, by labeling, advertising, and promotional claims.
We note that products that are not intended for use in the diagnosis of a disease Of other
conditions, or in the cure, mitigation, treatment, or
of disease, including
smartphones, tablets, and apps, even when used in a health care setting, would not be
considered to be medical devices.
4. How many mobile medical apps have sought approval from the FDA before entering
the market? What was the processing time for each ofthese apps? How many mobile
medical apps have been sub.jecf to oversight by the FDA after introduction to the
market? How many apps have either been changed or removed from the market by
FDA oversight, and why?
It is imponant to note that FDA has been regulating medical deviee software for decades and
medical device software on mobile platfonns for more than 10 years. During the past 10
years, the Agency has revievv'ed more than 30,000 premarket medical device submissions,
including approximately 100 for mobile medical apps. However, FDA traditionally has not
categorized or tracked premarket submissions based on the specific underlying technology of
a medical device. Rather, our systems have been focused on capturing devices that generally
fall within device classifications that are grouped by medical specialties (for example,
radiology; ear, nose, and throat; toxicology; dental; ophthalmic; etc.). We are currently
exploring methods to better capture the number and types of mobile medical app
submissions.
For 2011 and 2012, the average time for FDA review of medical device submissions that
were identilied as containing a mobile medical app was 67 days and the average total time
from submission to FDA decision was 110 days, These numbers represent review of not
only the mobile medical app, but also review of any relevant attachments or accessories
included in the submission. For example, review of a submission of a glucose meter
included evaluation of both the mobile medical app and the blood glucose attachment.
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In general, manufacturers often voluntarily correct their products that

either be in
violation of the FD&C Act or experience a malflll1Clion that could result serious injury or
death. We are aware of one voluntary recall invohing a mobile medical app that could
miscalculate an insulin dose potentially resulting in dangerously low or high blood glucose
levels in diabetic patients. In addition, the app was unintentionally made available in the
United States by the manufacturer. The mannfacturer voluntarily notified all users
worldwide and removed the app from the Global App Store.
60
Page 4
As requested in your letter, appropriate FDA representatives briefed staff of the COllUuittee
on Energy and Commerce and discussed these issues by telephone conference on Thursday,
March 14, 2013.
Thank you, again, for contacting us concerning this matter. lfwe can be offnrther assistance,
please let us know. The same Jetter has been sent to your cosigners.
Sincerely,
Michele Mital
Acting Associate Commissioner
for Legislation
cc;
The Honorable Henry A. Waxman, Ranking Member
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The Honorable Diana DeGette, Ranking Member

Subcommittee on Oversight and Investigations
61
Thc Ilonorable Tim Murph~

Chairman
MAY
02013
Subcommittee on Ovcrsight and Investigations

I,jouse of Represent;iives
\Vashington. D,C. 20515-6115
Dear ML Chairman:
Thank you for providing the opportunity tl>r the Food and Drug Administration (FDA or the
Agency) to testify at the March 2 L 20! 3. hearing before the Subcommittee on Oversight
and Investigations. Committee on Energy and Commerce. entitled "'lleallh Information
Tcchnologies: Administration Pcrspectives on Innovation and Regulation." This letter
provides responses for the record to questions posed by certain MCl'nbers of the
Subcommittee. which \\c received on April 9, 2Dl2,
If you have thrthe,. questions, please let us know.

Sincerely.
Michele IVlital
Acting Associate Commissioner
for Legislation
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The Honorable Diana DeGette

Ranking Member
and In\'e~tigations
Subcommittl;:'e on
Commerce
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tc:
62
Page 2 - The llonorable Tim Murphy
We have restated each Member's questions below in bold. lb!lowed by OUf responses.
1. The
slates that the FDA's proposed
to mobile apps that perform the
mobile medical ap!>
(EHR) system or
health record
fUllctiionalilty of an eiectronie health
system. Has the FDA iUIl!
discussions or conducted
on how this
will
to the
insurance
that
debut on
li,
2014 as part oftbe Patient Protection and
Care Act? Will any mobile
lIPpS related to the
be
to this Same statement?
fDA's proposed policy would focus its regulatory oversight on only a subset of mobile
medical apps that meet the definition ofa device in section 20l{h) ofthe Federal Food.
Drug, and Cosmetic Aet (FD&C Act) and are intended to be used as an accessory to a
cleared/approvcd medical device, or to tnmsibrm a mobile platfoml into a clcared/approved
medical device. We are not awarc of any mobile apps related to health insurance exchanges
under the Patient Protection and Ailbrdable Care Act that meet that definition,
2.
your
indicated that FDA had provided technical guidance to
the ~nternal Revem.le
to
the Medical Device Tax created
the
Patient Protection and Affordable
Act. Please
dds for the
\Vc are in receipt oflhe April 9. 2()13, tener to FDA on this issue from Chainnan Fred
Upton, House Committee on Energy and Commerce, Chairman Tim Murphy, Subcommittee
on Ovcrsight and
and Rep. Morgan Griffith. We will respond to this request
under separate cover.
3. Both
that
written
and responses to questions at the
indicated
willl.lltilize its
discretiun in
a mobile
medical apE> will be regulated more carefully (and
subject to the
Mcdie<.d Devie Tax). Are there
in wbich that discretion
not be
necessary? If a previous or furore
indicates that manufacturers
should automatically
with the
or otherwise notify the FDA srilleil'
intentions, could that trigger increased
Will the use
enforcement
discretion occur on a case
case basis or win there be certain
that
guarantee a mobile
requires inreascd oversight, outside of the
listed in tbe
guidance?
wm
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80807.033
FIJA's draft guidance. issued in July 2011. proposes our intent to exercise enforcement
discretion tlJr most mobile apps. As stated in our guidance. FDA is !bcusing. its regulatory
priorities on those mobile apps that mect the definition of device and are intended to (1) bc
used as an accessory to a cleared/approved medical device. 01' (2) transform a mobile
platform into a clcared/approved medical device. FDA typically makes its enforcement
63
Page 3 - The Honorable Tim Murphy
decisions on a case-by-ease basis and these decisions will be
forth in the final version of this >!U!U<HIU;.
by the principles set
To help darify tile Agency's policy for mobile medical apI's, FDA intcnds to post on its
website new examples of mobile apps on which FDA is focusing its priorities,
l. With the tbollsands of medical apI's that are cu....~'nltllv
does FDA have to approve the majority of these
developed, wbat plan

apps in a timely fashion'?
FDA has been reviewing medical device software for almost as long as FDA has had
premarket review authority for devices, Further, although there are thousands of mobile
apps on the market, relatively Jew have required FDA review. FDA has reviewed
approximately 100 mobile medical apI'S over the last decade. All of these apI's have been
reviewed as premarket notit1eation (5iO(k submissions. rather than premarket approval
applications (PMA).
Even with the recent increased growth and availability ofthese mobile apI's, in the last two
years FDA has received for clearance no more than 20 premarket notification (51 O(k
submissions per year for mobile medical apI's. For 2011 and 2012, the average time for
FDA review of medical device submissions that were identified as containing a mobile
medical app was 67 days. Under the FD&C Act. medical device 51 O(k) clearances are to be
completed within 90 days. and our data show that the Agency is well \vithil1 that time franle
in reviewing mobile medical app submissions.
FDA docs not anticipate a substantial increase in its premarket review workload due to an
increased number of submissions tl)r mobile medical apI's. Under FDA's propos<.'<i
guidance, most mobile apI's will fall outside of FDA's regulatory focus. Thc approach
propcsed in the Agency's July 2011 draft guidance on mobile medica! apI's states that
FDA's oversight will focus on a small subset of mobile apI's that arc similar to medical
devices that are clearedlapproved or that may affect the functionality ofdearedfapprovcd
medical devices.
2. Has FDA considered a 3-tiered, risk-bastd
framework for bealth
informatioll
medical appli, as discussed
McKesson in
testin!!lEllY before tile
and Commerce Health Subcommittee on Wcdnesday,
March
2013 and by the Bipartislln
Center in a February 2013 stlldy titled
"An Oversight Framework for Assuring Patient Safety in HIe'.hith Information
Technology"'?
As required by section 618 of the Food and Drug Administration Safety and Innovation Act
(FDASIA),! FDA is working with the Federal Communications Commission (FCC) and the
Department of Health and Human Services (HHS) Office of the National Coordinator for
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Public Law 112,144, 126 Stat. 9n (July 9, 2012).
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64
Page 4 - The Honorable Tim
a proposed strategy
Health Infol1nation Technology (ONe) to develop a report
and recommendations on an
risk-based regu!altlry framework pertaining to
health information technology that promotes innovation. protects patient
and avoids
regulatory duplication.
The three agencies are
a workgroup of exlemal stakeholders and experts, as
of Health and Iluman Services
suggested in section 618
under the
Health Information Technology (HIT) Policy Committee. This wi!! allo\\" for diverse
stakeholder groups to
input to the HIT Policy Committee on the proposed strategy
and recommendations
the risk-based regulatory framework for health information
technology. The working group will be
with providing input on a tiered, risk-based
regulatory framework that appropriately addresses patient safety and innovation and avoids
regulatory duplication. We intend to consider all
proposals, including the
approaches that were described in the testimonies before the Health Subcommittee of the
House Committee on Energy and Commerce during the ?...1arch 20, 2013, hearing entitled
"Health Intormation
How Innovation Benefits Patients."
3. If so, does the FDA need

to facilitate the ,...,,,,,~,,,'~
Im'l)!emE!ntlttnm of a 3-tiercd, risk-based
and
fill' health
adl~ptilln
,.. r" ..." ..t'"'' tell:lnnOiogy, including medical

Please sec response to Question #2 above.
1. The world we live in is filled with resourees for everyday folks to

their
symptoms by
adviee websites, and countless m!:UtcIIIIHI'm!.'leu
llppS. I am a
proponcllt of consumcrs
direct access to information, but
do you have any Cllncerns about il!ldividuals using these
to
and
not
their doctor or other healtheare
you talk
moment about the impact these medical apps Illn'c bad on eonsumer actions'!
Certain health-related mobile apps can improve the care and quality of life for many people,
giving them tbe freedom to conveniently access health-related infonnation that can help
them make important decisions about their care. Mobile apps that motivate Individuals to
and eating a healthy diet)
providing
lead a healthy lifestyle (tor example. by
information and education are good examples
mobile technology has enhanced
people's lives and helped them manage their conditions. We cncourage consumers of these
types of apps to consult their physicians and other health care professionals before making
any lifestyle changes that could potentially affect medical conditions.
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For other types of mobile apps that are

to help individuals diagnose illnesses, there
is always the risk that consumers \lIouId not seek treatment when they should. We believe
that consumers should make informed decisions and so instead of solely relying on
65
Page 5 - The llanorable Tim Murphy
technology to diagnose a disease or health-related condition. they should also consult a
licenscd medical practitioner, as ar>!JrGIPri'lIe.
1\10bile medical apps that allow consumers to
a disease must be shown to be
sate and effective so that consumers can rely on them as they would rely on a blood glucose
meter or an over-the-counter blood pressure cuff,
oversight on these types of mobile medical apps. to
FDA intends to focus its
ensure that this technology. which enables consumers and patients to diagnose serious
diseases or conditions or that may be used to make important treatment decisions. is safe and
effective.
2.
mobile
wheIDI their creators or conSUmers
will tile FDA
with new
notice problems that reqllire correction.
gcnerations of web
and help ensure COIDIUmCl"S IIlfC
safe and
accurate mobile
FDA's proposed mobile medical apps policy would not

mobile medical
product ehangcs that
not
developers to scek
re-evaluation tor minor,
significantly affect
and effectiveness of the mobile app. Even for the small subset
of mobile medical applications that FDA would actively regulate, such changes could be
made without notification to FDA, provided that the manufacturer complies with applicable
Quality System requirements in making such
For changes that significantly afTect
and effectiveness of the mobile medica! app,
FDA would take a risk-based approach that primarily relies on manufacturers to have
Quality System processes in place. Significant changes made to higher-risk regulated
mobile medical apps may be subject to certain additional oversight by FDA, in order to
ensure that such changes do not adversely affect the saiety and effectiveness of the device.
nr01tICII':iv with ail m"",ru,"... ",,,mobile
3, Certain mobile appUcatiorms
device. How Cllin we llissist in COlllUlllUllticati,ng
are
"",,,,..,,,,,.,,,1".. for their indi"'idual mobile
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The mobile apps industry plays an important role in

standards in areas such as
device compatibility. Some industry groups have already begun activities in developing
open architectures and standards with rcgard to expectations tor compatibility, FDA can
industry, and standardalso playa role, by participating with health care
setting organizations in standard-setting activities.
66
QUESTIONS FOR THE RECORD: Farzad Mostashari, National Coordinator for Health Information
Technology, U.S. Department of Health and Human Services
"Health Information Technologies: Administration Perspective on Innovation and Regulation" - March
21,2013
Committee on Energy and Commerce, Subcommittee on Oversight and Investigation, U.S. House of
Representatives
Chairman Murphy
Question 1:
Page 7 of your testimony notes that a November 2011 10M report reported that "market forces are
not adequately addressing the potential risks associated with the use of health IT." Has ONC
experienced this? Does ONC believe that market forces are not adequately addressing patient safety
or other risks?
ONC believes that on the whole, the adoption of health iT has greatly improved patient safety by
reducing medical errors and helping to standardize the way that care is provided, but we are mindful of
the need to ensure that new systems are built and used in the safest possible manner. We believe
market forces have already motivated a high level of safety in the industry, but there is opportunity for
improvement. For instance, in 2014, certified EHR technology developers will be required to publicly
identify a method of incorporating user-centered design that has a high likelihood of helping to prevent
medical errors. Certified EHR technology developers will also be required to provide transparency
regarding their approach to quality management systems.
In our draft Health IT Patient Safety Action and Surveillance Plan, we encouraged the industry to draft
and enforce a voluntary code of conduct to improve safety practices, among other things. We will
continue to monitor the industry's progress in addressing potential safety risks going forward.
Question 2:
Page 8 of your testimony notes that ONC's draft plan on Health IT Patient Safety will recommend the
inclusion of "safety requirements related to user-centered design ... and easier reporting of adverse
events ... n Can you elaborate on the authority given ONC to either compel or recommend that these
items be included? How will this be enforced, if ONe chooses to endorse this approach?
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The draft Health IT Patient Safety Action and Surveillance Plan (the Safety Plan) restates ONe's
commitment to patient safety through the safe use of health IT. Prior to the Safety Plan's release, ONC
had already adopted through rulemaking two safety-related 2014 Edition certification criteria for EHR
technology. The first certification criterion requires that EHR technology presented for certification to
anyone of eight specific medication-related capabilities must have had user-centered design processes
applied to them in order to be certified. The second certification criterion requires the identification of
the quality management system followed and used in the design of the EHR technology. Given that
these requirements are part of ONe's HIT Certification Program, they will be primarily enforced by the
certification bodies ONC has authorized to perform certifications and, generally, by ONC in providing its
overall program oversight.
67
Question 3:
One of the main concerns about the push for the meaningful use of health IT is that we may be
encouraging doctors and patients to rely more heavily on computers or the internet than face-to-face
interaction. Do you have any evidence that the use of health IT is better or worse than interaction
between a doctor and patient? Have any studies been done on the possibility this could decrease
patient safety?
Meaningful Use does not replace appropriate physician-patient interaction or in any way encourage
virtual interaction when face-to-face is best warranted. Its application encourages more productive
interactions by enabling physicians to make more fully informed pOint-of-care decisions and
recommendations. Just as the advent of the telephone did not preclude, prevent, or disable the need for
face-to-face interaction between the patient and his/her doctor, health IT and Meaningful Use provides
yet another timely conduit for information exchange.
One of the most recently published reports by David Radley, et. aI., describes how the use of
computerized provider order entry (CPOE), a central component of Meaningful Use, decreases the
likelihood of prescribing error by 48%1 ONC believes the application of this tool has tremendous
potential to improve patient safety.
Question 4:
Many complaints have been made about the problem of interoperability - health IT systems that
cannot communicate with each other - in fact you were asked about this during questioning. What
does ONe plan to do to finally solve this problem?
Health IT and the secure exchange of information across providers are crucial to reforming the system.
In 2014 EHRs will be significantly more interoperable because providers will have to demonstrate that
they can exchange clinical information with other providers.
More specifically, starting in 2014 hospitals, doctors, and other eligible professionals that use certified
EHR technology in Stage 2 of Meaningful Use will be able to share summary records across providers,
send electronic prescriptions, electronically report clinical quality measures, and allow patients to view,
transmit and download their health information. These advances, combined with the ongoing work ONC
is doing to develop standards for health information exchange, will continue to drive increasing levels of
interoperability over the coming months and years.
In addition, we are currently considering which policy levers might be able to strengthen the business
case for the exchange of health information by making sure that different providers and vendors have
the strongest possible incentive to share information. In March, ONC and eMS jointly issued a request
for information (RFI) seeking public input on this issue. We have received over 200 comment letters
from a wide variety of stakeholders, which we are reviewing.
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I Radley, D. C., Wasserman. M. R .. Olsho. L. E. W .. Shoemaker S. J, Spranca. M.D., Bradshaw, B. Reduction in

medication errors in hospitals due 10 adoption ,!lCOmpuleri=ed pro)'ider order enfly systems. JAm Med Inform
Assoc
470-476 Published Online First: 20 February 2013 doi:lO.1136/amiajnl2012-001241 (available at
lillJ.li,williilml.i.&ill.ll!Q1l!l::!llL:;QihllflJQi:!.) (last accessed 4/15/20 13)
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We are also encouraged that others have increasingly recognized the progress that is underway. At a
th
recent hearing on HIT standards and interoperability that took place on November 14 , 2012 before the
House Committee on Science, Space, and Technology, Subcommittee on Technology, all five witnesses
stated that progress is being made on interoperability. Similarly, in an October, 2012 report on
information sharing, the Bipartisan Policy Committee stated that a business case for electronic health
information sharing is beginning to emerge, and also that the Meaningful Use Stage 2 requirements that
take effect in 2014 largely address a majority of the information sharing needs that have been identified
in clinician surveys.
Question 5:
Does ONe see a problem with information sharing among psychologists or behavior health workers?
Were Health IT incentives offered to this group? Why or why not?
ONC has worked with the HHS Substance Abuse and Mental Health Services Administration (SAMHSA) to
clarify the federal protections over substance abuse information in the context of health information
exchange.' These efforts led to the publication of FAQs "Applying the Substance Abuse Confidentiality
Regulations to Health Information Exchange (HIE). Further, in September 2012, in partnership with other
components of the Department of Health and Human Services (HHS) and with the Department of
Veterans Affairs (VA), ONe, through its Data Segmentation for Privacy Initiative (DS4P) demonstrated
that with proper standards in place, existing privacy laws and poliCies can be implemented appropriately
in an electronic environment. Using standards identified in the DS4P Initiative, SAMHSA and the VA
safely and securely transmitted a mock patient's substance abuse treatment records tagged with privacy
metadata from one EHR to a different EHR system after electronically verifying that the mock patient
had consented to the transmission.
Health IT incentives were not offered specifically to psychologists or behavioral health workers, and only
mental health professionals who meet the definition of an eligible professional (EP) could qualify to
receive EHR incentive payments under Medicare or Medicaid. The specific criteria for Medicare or
Medicaid EPs can be found at the following link: http://www.cms.gov!Regulations-andGuidance/Legislation!EHRlncentivePrograms!Getting Started.h.J:ml.
Question 6:
The Health Insurance Portability and Accountability Act (HIPAA) protects the privacy of an individual's
health information. How does ONC balance the requirements of HIPAA with the benefits of Health IT?
What conflicts or barriers exist? In particular, are there any specific barriers or problems related to
mental health records that ONe has encountered? Has ONe done any analysis or identified any
problems related to HIPAA and the coming health insurance exchanges established by the Patient
Protection and Affordable Care Act?
ONC recognizes the importance of protecting the privacy of patient health information while at the
same time encouraging greater use of health information technology (Health IT) in order to achieve
significant improvements in areas such as health care quality and cost control. ONC works closely with
other Health IT stakeholders to create a culture where ensuring the confidentiality, integrity and
availability of electronic health information is seen less as a barrier to health information exchange than
as a valued, shared cultural norm.
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With respect to HIPAA, ONC is not aware of any specific problems related to mental health records and
the use of Health IT. For the most part, the HIPAA Privacy Rule treats mental health records in the same
manner as any other protected health information {PHI}. Under the Rule, a health care provider
generally may use and disclose protected health information, including mental health records, for the
key health-care related purposes of treatment, payment, and health care operations without obtaining
the patient's express written authorization. While the Rule generally does require patient authorization
for a covered health care provider to disclose psychotherapy notes (Le., notes recorded by a mental
health professional documenting the contents of a private or group counseling session which are
maintained separately from the rest of the medical record), such notes are subjective to and for use by
the originating provider and thus, access to the notes is rarely needed by other health care entities for
treatment or other purposes.
Finally, with respect to the coming health insurance exchanges, ONC reviewed and contributed to the
Patient Protection and Affordable Care Act (ACA) regulations, to help ensure that privacy, security, and
data stewardship policies were appropriately incorporated into the final rules governing the new modes
for exchanging and analyzing health information under the ACA. This effort addressed regulations
governing: 1) accountable care organizations; 2) qualified entities that provide performance
measurement services, 3) and the health insurance marketplace.
Representative Johnson
Question 1:
As an IT professional for 30 years, I understand the vital importance of IT architecture and having a
road map to achieve the end state. As they say, if you don't know where you are going, any road will
get you there.
When ONC and CMS together published the original set of rules setting up the Electronic Health Record
Incentive Program in 2010, we articulated long-term goals for the program that continue to serve as a
useful roadmap as the program evolves over time (see 75 FR 44321). We continue to believe that
certified EHR technology used in a meaningful way is one piece of a broader HIT infrastructure that will
ultimately help reform the health care system and improve health care quality, efficiency, and patient
safety. We look forward to working with you as we continue to pursue this vision.
Question 2:
With regard to the Meaningful Use Program currently in place to guide implementation of electronic
health record (EHR) systems, how is HHS ensuring that we aren't just collecting and digitizing data?
Were the stages of Meaningful Use crafted with an IT architecture in mind that spans all stages to
achieve a specific end? If so, then how?
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Starting with the first proposed rule on Meaningful Use Stage 1 issued in January 2010, HHS laid out its
vision for what Stages 1, 2, and 3 would look like and focus on. With that vision in mind, we worked
backward and charted an ambitious yet incremental course for the industry. We also took care to
ensure that each Meaningful Use stage would build on the next. Thus, as an eligible provider progresses
from one stage to the next they are asked to use the data in their EHR technology (and the technology
itself) in specific ways that will help enhance care delivery and improve patient engagement. As we
consider policy for Stage 3, we will continue to work toward the vision we laid out with a careful interest
70
in making sure that the experience eligible providers' gain through Stages 1 and 2 can be applied in
Stage 3.
Question 3:
Information must also be relevant and functional for the end user. How have you involved health care
providers in the development of this road map to ensure that the time, money, and effort put into
these systems will be worth their while and create an integrated, coordinated care system that
streamlines their work? What concerns have these providers had with regards to EHR and Meaningful
Use stages and how has HHS worked with these individuals to address them?
Health care providers and other health professionals have been involved at every step of HHS's policy
development processes for Meaningful Use. The HIT Policy Committee, which has made policy
recommendations regarding Meaningful Use, includes healthcare providers that participate in the EHR
Incentive Programs - for instance, the Committee's Meaningful Use Workgroup includes 8 medical
doctors (including both co-chairs), 2 registered nurses, and a variety of other stakeholders who
represent the health care industry more broadly. ONC and CMS openly solicit feedback from provider
organizations during our rulemakings, and HHS employs several staff with significant clinical experience
working with electronic health records. In both our Stage 1 and Stage 2 rulemaking processes, we
introduced significant new flexibilities for providers into our final rules in response to public comments.
Some provider concerns are unique and specific to their practice/setting while others are more general.
To educate providers about program requirements, HHS has produced a significant amount of
downloadable education materials, increased the number of webinars and education sessions, and
regularly communicated with provider associations to help spread the word. We have also devoted a
considerable amount of resources toward the 62 Regional Extension Centers (RECs) that have been
established across the country through cooperative agreements funded under the Health Information
Technology and Clinical Health (HITECH) Act. The personnel that work in the RECs are local experts and
work hand-in-hand with health care providers along every step of the way - from selecting an EHR to
getting to meaningful use. We have also established a virtual infrastructure of communities of practice
to enable healthcare providers to share best practices with each other and to communicate feedback
directly to HHS.
Representative Butterfield
Question 1:
Many rural parts of my congressional district are desolate and where the nearest primary care doctor
can be an hour or more drive away. East Carolina University located in my district in Greenville, North
Carolina has been operating a telemedicine program since 1992 - making it one of the oldest
telemedicine programs in the world. Recognizing that there is a dear link between access to care and
improved health, what other resources in addition to telemedicine are available now to link the rural
elderly and indigent populations to healthcare providers like primary care doctors and physician's
assistants? What is on the horizon?
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Medicare pays for certain telehealth services to beneficiaries in rural communities. Medicare pays for
these services when they are furnished at specified originating sites that include physicians' offices,
critical access hospitals, rural health clinics, and federally qualified health centers, and when those sites
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are in either a rural Health Professional Shortage Area (HPSA) or a non-Metropolitan Statistical Area
county.
In addition to telehealth, there are a number of programs available to help link the rural elderly and
indigent populations to health care providers. HHS administers the Rural Health Outreach program,
which provides grants to rural communities to test out new ideas and develop models for improving
access to care. This program includes funding for rural health networks that help rural providers work
together to build better systems of care.
As authorized under Section 3026 of the Affordable Care Act, HHS is also partnering with community
based organizations and acute care hospitals under the Community-Based Care Transitions program to
improve transitions of beneficiaries from the inpatient hospital setting to other care settings, to improve
quality of care, to reduce readmissions for high risk beneficiaries, and to document measurable savings
to the Medicare program. One of these partners, Access East Community-based Transitional
Partnership, is located in Greenville, North Carolina.
Question 2:
Recently, Congress passed legislation that requires the Department of Defense to expand
telemedicine opportunities to service members regardless of whether they are on a base or in a
home, and regardless of where the doctor is licensed. Are there ways we can use this model in other
federal programs like Medicare to better expand access to care via telemedicine?
The Center for Medicare and Medicaid Innovation is testing several projects related to increased use of
telehealth. A project in Hawaii received a Health Care Innovation Award for telehealth-based home
monitoring for very high risk patients with complex health care needs in order to prevent
hospitalizations. A project in Wyoming received a Health Care Innovation Award to improve care
coordination and communication with practitioners in ten rural Iowa counties using telehealth and webbased personal health records.
In addition, under the Affordable Care Act, accountable care organizations (ACOs) participating in the
Medicare Shared Savings Program agree to coordinate care for beneficiaries, such as through the use of
telehealth, remote patient monitoring, and other such enabling technologies.
Question 3:
The VA has moved to mostly eliminate cost sharing on telemedicine, recognizing treating veterans at
home is less expensive than treating them in a VA facility. For example: The Veterans
Administration's home telehealth program has resulted in a 30 percent reduction in hospital
administration and a 20 percent decrease in hospital stays. How can Congress build off this model
and achieve similar outcomes in other federal healthcare programs?
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The Veterans Administration has long been a pioneer in the use oftelehealth technology. In addition,
the Health Resources and Services Administration has awarded funding for using tele-home care
services. The CMS Center for Medicare and Medicaid Innovation (Innovation Center) has also funded a
number of new models using telehealth technology. The Innovation Center is testing innovative
payment and service delivery models that have the potential to reduce expenditures while preserving or
enhancing the quality of care provided to Medicare, Medicaid, and CHIP beneficiaries. Participants in
the testing of all of the models are encouraged to use health information technology, and we
understand that they are using a variety of different technologies.
72
Currently, under the fee-for-service Medicare benefit, Medicare has the authority to pay for
telemedicine services for beneficiaries in specified rural communities provided by specified providers.
Section 1834(m) of the Social Security Act authorizes Medicare payment for telehealth services. The
statute requires that the originating site for telehealth services be in an area designated as either a rural
health professional shortage area, or a county that is not included in a Metropolitan Statistical Area.
The statute lists certain services that are considered telehealth, but also allows for the addition of other
telehealth services. CMS annually evaluates whether to add additional services to the telehealth
benefit, and last year in the final rule for the CY 2013 Physician Fee Schedule, a variety of new services
were added. Some of these new services include: alcohol and substance abuse and intervention
services; annual alcohol misuse screening; annual depression screening; intensive behavioral therapy for
cardiovascular disease; and intensive behavioral therapy for obesity.
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House Hearing, 113TH Congress - Health Information Technologies: Administration Perspectives On Innovation and Regulation

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House Hearing, 113TH Congress - Health Information Technologies: Administration Perspectives On Innovation and Regulation

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HEALTH INFORMATION TECHNOLOGIES: ADMINISTRATION PERSPECTIVES ON INNOVATION AND

SUBCOMMITTEE ON OVERSIGHT AND

COMMITTEE ON ENERGY AND

MARCH 21, 2013

Serial No. 11322

For sale by the Superintendent of Documents, U.S. Government Printing Office

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COMMITTEE ON ENERGY AND COMMERCE

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TIM MURPHY, Pennsylvania

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Hon. Tim Murphy, a Representative in Congress from the Commonwealth

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Mr. MURPHY. All right. Good morning, everyone, and welcome to

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HON. TIM MURPHY

Today we convene the Subcommittee on Oversight and Investigations to discuss

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Ms. DEGETTE. Thank you very much, Mr. Chairman.

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Mr. BURGESS. I thank the chairman. And certainly we have

Mrs. BLACKBURN. And I thank the gentleman for yielding. And

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Ms. FOREMAN. Mr. Chairman, Ranking Member DeGette, and

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